Recall Index 2025 edition 1: Product safety and recall United States edition PDF Free Download
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The report collects and analyzes recall data from the
U.S. National Highway Trac Safety Administration
(NHTSA), the U.S. Consumer Product Safety
Commission (CPSC), the U.S. Food and Drug
Administration (FDA), and the U.S. Department of
Agriculture (USDA) to provide exclusive insights
to help businesses protect their brands against
operational risk and reputational damage.
This edition reviews recall data from Q1 2025,
covering January through March, and provides
an early look at April data. Quarter over quarter,
the total number of recalls fell slightly from 780
in Q4 2024 to 775 in Q1 2025. The number of
Pharmaceutical, USDA Food, and Consumer Product
recalls increased in the same period, with Consumer
Products hitting a 14-year high. While there were
fewer recalls for the Automotive, Medical Device, and
FDA Food industries, the totals were not dramatically
dierent from other recent quarters.
The total number of units recalled across all tracked
industries increased by 24.8% compared to the
previous quarter. There were 125.37 million units
impacted by recalls, even though only FDA Food and
Pharmaceuticals saw an increase in recalled units
this quarter compared to Q4 2024. The volume of
FDA Food recalls increased by 232.1% to the highest
total in the past seven quarters.
In contrast, the number of units recalled in the USDA
Food, Consumer Products, Medical Device, and
Automotive sectors fell. There were 3.73 million
units impacted in the Automotive industry, the lowest
quarterly total in over 12 years.
In addition to the latest recall data, Sedgwick’s Recall
Index report also provides critical analysis and unique
perspectives on what lies ahead, including new
regulations and evolving priorities from lawmakers.
We include exclusive insight from some of our
strategic partners at global law rms, insurance
companies, and regulatory and safety organizations to
help businesses protect their brands and mitigate risk.
Taris and trade remained key issues across all
industries in Q1 2025. The unpredictable duties
and rapidly changing policies impacted markets
and continue to cause uncertainty globally as we
move into Q2.
The Trump Administration has rescinded many of
the Biden Administration’s Executive Orders and
has targeted other policy decisions, including those
around automobile emissions and AI regulations.
There have also been drastic cuts to federal agency
sta and a reduction in federal funding for many
projects, including pharmaceutical research. This
will likely aect enforcement actions and slow
some regulatory approval processes. Experts are
predicting widespread changes to how food and food
ingredients are regulated under the new Secretary of
Health and Human Services (HHS), some of which
are already in motion.
Sedgwick’s Product Safety and Recall Index report is the leading resource for
manufacturers, suppliers, and retailers seeking an unbiased, informed perspective on
past and present trends, as well as predictions about what’s next in product safety and
product recalls. It reviews five product categories: Automotive, Consumer Products,
Food and Drink, Pharmaceutical, and Medical Device.
Introduction
The current dynamic atmosphere in the U.S. makes
this report even more valuable as businesses work to
protect their brand and improve their operations. We
invite you to read the entire report cover to cover, or
just focus on the sections that matter most to
your industry.
One nal note: This edition of the Product Safety
and Recall Index focuses on U.S. recall data and
regulatory developments. If your business also
operates outside the U.S. or your supply chain is
aected by global issues, we recommend that you
also read our European edition.
Like this report, it shares recall data from regulatory
agencies and oers exclusive analysis around product
safety and policy changes—but from the perspective
of companies and regulators operating in the UK and
the European Union.
We have also added a biannual Australian Product
Safety and Recall Index report to our portfolio to
provide insights on regulations and recall data for
that market.
Q1 2025 European edition: click here
H2 2024 Australian edition: click here
If you would like more information about what we
have observed in recent quarters, you can nd
previous editions of the Recall Index below:
Q4 2024 U.S. Recall Index: click here
Q3 2024 U.S. Recall Index: click here
Q2 2024 U.S. Recall Index: click here
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 3
Thousands of recall events impact global industries
each year, and even those manufacturers with
robust recall plans often encounter unexpected
hurdles when it comes to facing a live event.
Whether you’re well versed in product recall
management or new to the process, take our
short online audit and receive a comprehensive
report featuring personalized insights and
strategic recommendations tailored to your
unique risk prole and needs.
How recall ready
are you?
Don’t wait until a recall strikes.
Safeguard your brand and your bottom-line.
.recall-ready.app
In January, the United States Court of Appeals for the Fifth Circuit vacated the Federal
Trade Commission’s (FTC’s) Combating Auto Retail Scams Trade Regulation Rule (CARS
Rule). The regulation was designed to protect consumers from bait-and-switch scenarios,
junk fees, and other illegal tactics when buying a car, though automobile dealers claimed
it was overly burdensome. Attorneys with Mayer Brown caution that state regulators may
increase enforcement of alleged misconduct around pricing and other issues the CARS
Rule was developed to prevent.
In addition, the Trump White House issued an Executive Order (EO) in January rescinding
President Biden’s EO and other related actions that set a goal of having 50% of all new
passenger cars and light trucks sold in 2030 be zero-emission vehicles. The order would
have developed similar rules for medium- and heavy-duty engines and vehicles for model
years 2027 and beyond.
The National Highway Trac Safety Administration (NHTSA) is advancing a new rule that
will require automobile manufacturers and dealers to supplement written notications about
a product recall with electronic communications. The aim is to ensure that vehicle owners
know about safety concerns and to increase the completion rate of repairs.
In March, a nal rule from the Department of Commerce’s Bureau of Industry and Security
(BIS) went into eect. The measure bans the import of specic “vehicle connectivity system”
(VCS) hardware and the import or sale of certain connected vehicles that incorporate
software related to vehicle connectivity or automated driving systems (ADS) from China
or Russia. The measure places serious compliance and due diligence obligations on
automotive manufacturers and suppliers of VCS hardware and software and ADS
software. It could also impact the availability of hardware, software, and vehicles.
Stakeholders can expect many changes across the automotive industry as the Trump
Administration works to put its stamp on manufacturing and trade.
Automotive
During the first quarter of 2025, U.S. automakers and dealers faced
significant challenges due to tariffs on imported steel, aluminum,
vehicles, and vehicle parts as well as the retaliatory duties other
countries have placed on imported U.S. vehicles. There have been
several stops and starts, which has disrupted planning efforts and
created ongoing supply chain and pricing concerns.
“With new NHTSA rules expanding recall notification
requirements, automakers must strengthen
communication strategies to boost repair
completion rates and reduce safety risks.”
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 9
Tariff war creates challenges
for auto industry
The rst quarter was a roller coaster for automakers
and suppliers. As reported by lawyers with Barnes,
Richardson and Colburn, LLP, taris were announced,
adjusted, and paused multiple times. After taking
oce on January 20, President Trump announced
taris on all imports from Canada, Mexico, and China
on February 2, set to begin February 4, though duties
on Mexico and Canada were paused on February
3. China retaliated on February 4 with taris on U.S.
pickup trucks and “large displacement cars.”
Less than a week later, President Trump announced
taris for all steel and aluminum and their derivatives,
a total of 232 product categories, though changes
and exclusions were announced over several weeks.
The new steel and aluminum taris went into eect on
March 12. In response, the EU announced retaliatory
taris on U.S. goods, including motorcycles, bourbon,
peanut butter, and jeans. Later that day, the EU said it
would pause these taris until mid-April. Canada also
announced plans to impose retaliatory taris worth
$20.7 billion on U.S. imports eective March 13.
On March 26, President Trump announced 25%
taris on auto imports that will be collected starting
on April 3 for fully-imported cars but expanding in
phases through May 3 to include applicable auto
parts, according to a report by PBS News. On April
3, Canadian Prime Minister Carney announced 25%
levies on vehicles imported from the U.S. to match
the new U.S. taris on automobiles.
The next big U.S. announcement was a 10% baseline
tax on imports from all countries, with higher taris on
dozens of nations that have trade surpluses with the
U.S. These reciprocal tari rates include a 20% rate
on imports from the EU, 25% on South Korea, and
24% on Japan.
Under this latest policy, Canadian and Mexican goods
that comply with the U.S.-Mexico-Canada Agreement
(USMCA) can be imported duty-free, though a 25% tari
remains on goods not covered in the trade agreement.
The increased “reciprocal” tari rates went into eect
on April 9, but were suspended the same day for 90
days, though the 10% levy on most global imports
was left in place. The next day China announced its
own plans to match the U.S. taris on Chinese goods,
including more export controls on rare earths metals
and trade sanctions or export controls on 27 U.S.
companies, in addition to 34% taris on U.S. goods.
On April 9, EU member states approved their own slate
of retaliatory taris on $23 billion of U.S. goods to roll
out in stages as early as April 15, with additional duties
taking eect on May 15 and December 1. These were
halted on April 10 in response to President Trump’s
pause on the higher taris.
Attorneys with Foley & Lardner LLP report that the
25% automobile and auto parts taris announced
by President Trump could cost the industry up to
$110 billion annually, according to investment
bank estimates.
Nearly 50% of new light vehicles sold in the U.S.
in 2024 were assembled outside the U.S., and up
to 70% of vehicles sold in the U.S. in a typical year
contain imported components. The taris on the
vehicles and parts could result in up to 15% higher
new-vehicle prices by May or sooner.
The automotive industry was already dealing with
uncertainty in the transition to electric vehicles and
ongoing supply chain challenges. The taris and their
impact on costs and supplies will be another challenge.
Legal experts with Frost Brown Todd LLP suggest
that automakers and suppliers consider stockpiling
inventory for goods that could become subject to
taris, as well as reviewing contracts for mechanisms
to recover increased costs caused by the taris and
for exibility when dealing with delivery delays.
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 11
NHTSA proposes new recall
notification rules
In January, the National Highway Trac Safety
Administration (NHTSA) issued a Supplemental
Notice of Proposed Rulemaking (SNPRM) to update
the requirements for how automotive manufacturers
must notify consumers about product recalls. Under
the draft rule, manufacturers of vehicles or vehicle
parts must issue recall notications to aected
consumers through electronic means, in addition
to rst-class mail.
In the SNPRM, NHTSA states that eective recall
notications are “critical to ensuring that as many
vehicles and items of equipment as possible are
remedied, addressing the safety risk of a defect
or noncompliance.” It also notes that a “multi-
channel, multi-touch approach helps to eectively
communicate a recall and motivate completion.”
Attorneys with Crowell & Moring LLP outlined some
of the key considerations in the proposal, including
the requirement that if a manufacturer doesn’t have
a way to directly send an electronic notication to
a specic owner or purchaser, that the company
must use other electronic means, such as public
broadcasts or social media campaigns, to reasonably
attempt to reach consumers.
The SNPRM also species the required content of
the electronic notication, stating that it must be
consistent with the written recall notice. It should
also include a link to a representative copy of the
written notice, an explanation of how to determine
if a vehicle is impacted, and direct consumers to
NHTSA’s or the manufacturer’s vehicle identication
number (VIN) search tool.
Once nalized, the mandate to issue electronic
notication will apply to all interim and nal recall
notications, as well as any follow-up notications
that NHTSA deems necessary.
The proposed rule allows manufacturers the exibility
to choose the channel of electronic communications,
including email, text, radio, television, in-vehicle
notications, social media or targeted online
campaigns, phone calls, or “other similar electronic
means.” However, they are required to provide
NHTSA with a general electronic notication plan
before the new rule takes eect. This plan should
outline the manufacturer’s anticipated means of
electronic notication and how they will select the
most eective channels. Manufacturers will need
to notify NHTSA if they plan to deviate from their
submitted plan and are also required to update
the plan at least every ve years.
Another provision in the draft rule is the need to
change references for “safety recall notice” and
“important safety recall” to “urgent safety recall,”
as well as other minor changes to website links
and other designations.
The public comment period ended on March 11,
2025. It is anticipated that once the rule is nal,
manufacturers will have at least one year after its
publication before they must comply. However,
manufacturers should begin to evaluate how they
will meet the electronic notication requirements,
especially if they don’t have current data to
accurately and eciently reach out to vehicle
owners or aren’t tracking current owners or
vehicles that are no longer in use on the road.
Ban on certain vehicle connectivity
system hardware and software
On March 17, 2025, a nal rule from the Department
of Commerce’s Bureau of Industry and Security (BIS)
on Securing the Information and Communications
Technology and Services Supply Chain: Connected
Vehicles took eect.
The rule bans the import of specic “vehicle
connectivity system” (VCS) hardware, including
connected vehicles integrating that hardware, and
prohibits the import or sale of certain connected
vehicles that incorporate software related to vehicle
connectivity or automated driving systems (ADS).
The restrictions apply to hardware and/or software
designed, developed, manufactured, or supplied by
persons owned by, controlled by, or subject to the
jurisdiction or direction of the People’s Republic of China
(PRC), including the Hong Kong Special Administrative
Region and the Macau Special Administrative Region or
the Russian Federation (Russia).
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 13
Lawyers with Akin Gump Strauss Hauer & Feld LLP call the rule “a signicant
escalation in trade restrictions” with PRC and Russia as they relate to
the automotive industry. According to the legal experts, the Department
of Commerce estimated that all new vehicles sold in the U.S., with few
exceptions, will be captured by its denition of “connected vehicles.” That
creates a “substantial risk” that certain imports and sales may be precluded
altogether beginning with Model Year 2027 for certain prohibitions.
Under the new rule, automotive manufacturers and suppliers of ADS software and
VCS hardware and software, face considerable compliance and due diligence
obligations. For example, VCS hardware importers and connected vehicle (CV)
manufacturers are prohibited from knowingly importing into the U.S. any products
that are designed, developed, manufactured, or supplied by persons owned by,
controlled by or subject to the jurisdiction or direction of the PRC or Russia. This
applies to both standalone products and hardware of software incorporated into
another product, such as software in a connected vehicle.
The nal rule expanded the denition of “connected vehicle manufacturer” to
include entities who purchase otherwise completed connected vehicles from
a third party and then integrate their proprietary ADS on the vehicle to enable
autonomous driving. There are some exclusions in the denition of VCS for
items that enable the transmission, receipt, conversion, or processing of
automotive sensing, ultrawideband communications to directly enable physical
vehicle access, or unidirectional radio frequency bands, as well as those that
supply or manage power for the VCS.
VCS hardware importers and connected vehicle manufacturers will need
to submit annual Declarations of Conformity to BIS to certify that they have
conducted due diligence in analyzing their VCS hardware and covered
software supply chains.
The measure continues to advance under the new administration. On March 1,
BIS issued an advance notice of proposed rulemaking (ANPRM) seeking public
comment on the draft rule. The comment period closed on April 30.
As the rule moves forward, attorneys with Morgan Lewis & Bockius LLP have
several recommendations for automakers and suppliers, including conducting
detailed supplier audits with a specic focus on VCS and ADS technologies
implicated by the Final Rule and re-examining sourcing strategies, especially for
key components such as connectivity and ADS systems.
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 15
As regulatory pressures intensify, it is crucial for
automakers and supply chain partners to assess
how prepared they are to withstand a product
incident or crisis, especially in light of NHTSA’s
recent $165 million civil penalty for a mishandled
recall. Sedgwick can help with its interactive
Recall Readiness audit.
Simply answer 15 quick questions and you’ll
receive a personalized “recall readiness
score” and a detailed report featuring tailored
recommendations based on your responses.
Protect your brand and bottom line today,
visit: www.recall-ready.app.
By the numbers
In Q1 2025, NHTSA issued 215 automotive
recalls—13.3% fewer than in Q4 2024. This
represents the second-lowest quarterly total in
nearly ve years and a 17.9% decline compared
to the same quarter last year, which recorded
262 recall events.
The number of aected units dropped sharply by
49.6%, falling from 7.41 million in the previous
quarter to 3.73 million in Q1 2025. This is the
lowest quarterly total recorded in more than
12 years. The largest single recall this quarter
involved 376,241 vehicles, due to a potential
loss of power in the steering assist system.
Electrical systems were the leading cause of
U.S. automotive recalls in Q1 2025, linked to
44 events—slightly down from 48 last quarter.
Equipment-related issues followed as the
second-most cited cause, involved in 33 recalls,
while power train issues were third, with 16
events reported.
By volume, electrical systems were also the
leading category, with 1.01 million units aected.
Back-over prevention ranked second with
497,588 units impacted. Steering-related issues
were third with 377,604 units aected—99.6%
of which were attributable to the single recall for
loss of steering assist power, noted above.
AUTOMOTIVE
Number of recall events by quarter
Number of recalled units by category (top 5)
Number of recall events by category (top 5)
190
Q2 2024
Q1 2024
Q4 2024
Q3 2024
Q1 2025
265
250
235
220
205
0
Equipment
Electrical
systems
Backover
prevention
Power train
Exterior
lighting
50
40
30
20
10
0
Backover
prevention
Electrical
systems
Seat belts
Steering
Power train
1.25M
1.00M
0.75M
0.50M
0.25M
How recall ready are you?
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 17
Typically, it is the original equipment manufacturer (OEM)
that formally issues a recall. However, a signicant portion
of recalls actually originate in the supply chain. This fact
is frequently overlooked since most media reports about
automotive recalls only name the OEM impacted and not the
company at fault for the defective part that led to the incident.
While media outlets report on the OEM responsible for
the recall, increasingly OEMs are not incurring all the
costs related to an event. Those costs are being pushed
down the supply chain to the company at fault more
frequently than in years past. As a result, a supplier may
be responsible for not only its own cost to repair or replace
defective products it has in its possession, but also for
costs its customer and the OEMs incur as a result of the
defect. These factors create a serious threat of potential
nancial loss that parts manufacturers and others in the
supply chain should take seriously.
The risk is increasing as taris cause companies to
reconsider the supply chain. First, as companies potentially
introduce new vendors, onboarding them can strain and
accelerate supplier verication eorts. This contrasts with
years past when diligent eorts would be taken to ensure
quality would not be impacted by changing vendors.
Weaker supplier verication could potentially lead
to increased product failure if new components are
interconnected and do not work correctly. These types of
circumstances already lead to many claims in the product
recall marketplace. This trend is expected to increase with
the remaking of the supply chain. Moreover, taris and
the general increased cost of doing business might cause
companies to neglect their own quality control investments and
specic protocols, which itself could result in more issues.
Over the past decade, automotive recalls have been on the rise due to more
complex vehicle technology, better detection systems for identifying defects,
and stricter safety regulations, among other reasons.
How to protect
against recall risks
MARTY DETMER, PRODUCT RECALL INSURANCE BROKER, AON PLC
Finally, taris that were introduced in the rst quarter on
steel, aluminum, automobiles, and automotive parts could
make repairing or replacing defective products that are
subject to a recall more expensive. If the parts required for
the x must be imported and thus are subject to a tari,
companies may face even higher costs to complete a recall
and there may be added delays in getting the parts.
All of these factors contribute to an environment where
proactive risk management becomes critical. Manufacturers
should focus on reviewing and evaluating supplier verication
programs and quality control procedures to ensure the
product is being delivered and made to their specications.
Moreover, a standard should be in place so that contractual
limits of liability are reviewed, negotiated, and understood by
dierent divisions of the company. This knowledge can help
companies better understand their exposure to losses and
inuence decisions on insurance solutions that could help
transfer risk relating to defective products.
In addition to having insurance policies that include a
robust product liability placement as part of a casualty
solution, manufacturers should also evaluate standalone
product recall insurance. These oerings can be used
to transfer the risk and liability of recalls that relate to
manufacturing or design defects.
Recalls can be viewed in the same context as the risk of
a re impacting a manufacturing facility. It is not a daily
occurrence, and steps are in place to prevent it from
happening. However, it might happen and if it does, it could
be detrimental to the business. Where recalls can dier
from a re is in severity and scope. The cost of a recall can
vary depending on the product impacted and the scale of
the incident.
The intent of a recall insurance policy is to cover the
Insured and the Insured’s customers for costs incurred
with the logistics of the recall. Arguably, the cost to repair
the defective product is the most important part of the
coverage. This cost often also includes the cost of market
removal and re-installation. The total amount can be
signicant depending on where the defective product is
located and how many units are impacted.
Recall policies can be triggered when the insured product
is recalled because it is defective and fails to perform the
function it was manufactured or designed to fulll. The
recall does not need to be mandated by a government
agency. Rather, the policy triggers on a voluntary recall
by the insured entity or that entity’s customer in the case
where the insured company’s product is at fault.
A standalone recall policy will not only cover manufacturing
and design errors by the policy holder, but it also is written
to cover a product defect that is caused by a vendor error.
Arguably, this safeguard against the supply chain is where
these solutions bring the most value.
A standard policy typically provides worldwide coverage,
but programs can be customized to t a company’s specic
needs—whether it is covering specic products, geographic
locations, or certain contracts.
The marketplace for product recall insurance is competitive.
It is large enough to allow brokers to oer recall program
coverage with limits exceeding $200 million, albeit most
companies generally purchase policies with limits of $25
million or less.
While there is surely interest from OEMs, these solutions
oered by the recall insurance marketplace are intended
for Tier One, Tier Two, or Tier Three suppliers that provide
component parts to OEMs.
Focusing on the component part suppliers gives insurance
underwriters the opportunity to understand the specic
product and appropriately underwrite the risk of a recall
originating from it. Underwriters contemplate placements for
all aspects of the automobile, even battery manufacturers.
Given the current market uncertainty, it may be the right
time for parts manufacturers and suppliers to explore recall
insurance solutions with a broker to protect their business
and their balance sheet.
The views expressed in this article are those of the author
and do not necessarily reflect the opinions of Sedgwick.
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 19
Taris complicated pricing and planning for consumer product manufacturers and suppliers
in Q1 2025. A urry of trade actions by the U.S. and retaliatory taris from other countries—
including a 145% tari imposed on U.S. goods from China and a 125% tari imposed by
China on U.S. products—contributed to supply chain instability. As of mid-April, many of
these taris had been paused, but uncertainty remains.
In addition to the taris, some domestic industries are also petitioning for antidumping and
countervailing duties on imported goods to protect U.S. manufacturers. The Department of
Commerce (DOC) and International Trade Commission (ITC) are investigating allegations
from American graphite producers that Chinese companies are selling active anode
material (AAM), a critical lithium-ion battery component, at unfairly low prices.
The new administration has already made signicant changes to the U.S. regulatory
approach to articial intelligence (AI). President Trump has rolled back virtually all of the
policies implemented by President Biden. Many experts predict a more hands-o regulatory
stance for AI under the new president.
Despite the changes to the administration, the focus of the Consumer Product Safety
Commission (CPSC) is expected to stay largely the same. It wants to keep infants and
children safe and keep unsafe products out of online marketplaces. Acting Chair, Peter
Feldman, has supported more scrutiny of Internet sales in his role as a commissioner
and will likely continue to support this issue in his new role.
Consumer products
In January, the Consumer Product Safety Commission (CPSC)
announced a $12.25 million civil settlement with a leading
smartwatch manufacturer. The agency claimed the company
knowingly failed to promptly report a defect in one of its
smartwatch models. That flaw resulted in consumers sustaining
second- and third-degree burns on their arms and wrists. Although
the company issued a recall in March 2022, the CPSC determined
that its delayed reporting of the defect was a violation of federal law.
“Manufacturers must act swiftly on product defects,
delays in reporting can lead to major penalties, as
CPSC ramps up enforcement and scrutiny.”
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 21
Trade group requests duties
on imported lithium-ion
battery components
At the end of 2024, the American Active Anode
Material Producers (AAAMP), a coalition of U.S.
graphite manufacturers, led petitions with the
Department of Commerce (DOC) and International
Trade Commission (ITC) seeking antidumping (AD)
and countervailing duties (CVD) on imports of active
anode material (AAM) from China.
AAM is a battery-grade graphite that is a primary
component in lithium-ion batteries and is critical to
the production of Battery Energy Storage Systems
(BESS), electric vehicles, consumer electronics,
medical equipment, and other devices. The AAAMP
alleges that Chinese AAM is being imported at
“less than fair value” (LTFV), with dumping margins
of 828% to 921%. The group is asking the DOC
to calculate these margins and the ITC to assess
whether U.S. producers are materially injured or
threatened with injury by these imports. The group
also requested that the DOC examine whether
Chinese manufacturers are receiving unfair subsidies
that lower their costs below competitive levels.
Lawyers with Holland & Knight LLP dene “dumping”
as the scenario when imported products are being
sold in the U.S. at LTFV. According to the legal
experts, if both the DOC and ITC nd in favor of the
petitioners, U.S. importers of the foreign goods must
post cash deposits for AD and/or CVD duties.
In January, the DOC launched a formal LTFV
investigation. In February, the ITC released
preliminary ndings showing a “reasonable indication”
of injury to U.S. manufacturers and announced it
would proceed with a full investigation.
Legal experts estimate nal CVD duty determinations
could be issued from the DOC in August and the
ITC by mid-July 2025. Final antidumping decisions
are projected in late August from the DOC and late
September from the ITC. Outcomes may also be
inuenced by ongoing U.S.-China tari negotiations.
Companies using AAM in their products should verify
whether it is coming from U.S. or foreign sources and
determine whether they want to explore new suppliers
or how they will manage the potential risk of dramatic
price increases if duties are imposed.
Changes to U.S. approach for
AI regulation
The Trump Administration moved quickly to overhaul
federal AI policy. The day he took oce, President
Trump rescinded several of the Biden Administration’s
Executive Orders (EOs), including one that required
companies developing AI to share information about
their technologies with the federal government before
selling their products to the public.
According to an analysis by lawyers with Barnes
& Thornburg, the only remaining AI-related Biden
directive pertains to using public lands for data centers.
On January 21, a new private venture, the Stargate
Project, was announced from the White House. The
company plans to invest $500 billion over the next
four years to build a new AI infrastructure for OpenAI
in the U.S.
Just days later, President Trump signed another EO,
Removing Barriers to American Leadership in Articial
Intelligence. The order asserts that to maintain its
leadership in AI innovation, the U.S. “must develop
AI systems that are free from ideological bias or
engineered social agendas.” The EO also revoked
current AI policies and directives that “act as barriers
to American AI innovation.”
Under the order, a select group of advisors, directors,
and agency heads must deliver to the president
within 180 days an action plan to identify policies,
directives, regulations, and orders taken pursuant to
President Biden’s EO on AI and suspend, revise, or
rescind such actions if they are inconsistent with the
objectives outlined in President Trump’s order.
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 23
On February 6, the White House Oce of Science
and Technology Policy (OSTP) issued a Request for
Information (RFI) seeking public input on the “highest
priority policy actions” to include in the action plan.
The RFI asked for feedback on 10 areas including
procurement, export controls, model development,
innovation and competition, and data privacy and
security through the AI life cycle. The comment
period closed on March 15.
The Trump Administration’s policies continue to evolve,
along with the dynamic AI space itself. Some experts
predict that the new administration will be largely hands
o when it comes to regulating AI. Others believe that an
absence of aggressive federal regulations will lead to a
rise in state lawmakers creating a patchwork of laws to
try to protect consumers and market competition. This
could lead to a fragmented regulatory environment.
Companies using or developing AI technologies
should monitor both federal and state policy
developments closely. In a market that is already
moving extremely fast, AI developers and companies
incorporating AI into their products and services will
need to be agile as the rules evolve.
CPSC’s priorities for 2025
The CPSC is focused on longstanding priorities in its
Operating Plan for Fiscal Year 2025, which runs from
October 1, 2024, through September 30, 2025. The
agency plans to target toys containing button cell and
coin cell batteries, as well as infant sleep products
such as support cushions and nursing pillows. Other
key concerns outlined in the plan are ensuring that
e-commerce platforms are complying with current
regulations and coordinating with state regulators
on enforcement.
In a statement in late 2024, CPSC Chairman
Alexander Hoehn-Saric voiced support for the plan
but raised concerns about how stang and budget
cuts could impact the agency’s ability to carry out
its mission. These cuts began under the Biden
Administration and are expected to continue
under the Trump Administration.
Chairman Hoehn-Saric specically called out a 61%
reduction to the CPSC’s International Programs
division. He described the department as a critical
rst line of defense for U.S. consumers. He also
noted that new constraints on sta participation
in voluntary standards activities may hinder the
agency’s ability to detect hazardous products at
ports of entry, retail locations, and online.
Commissioner Hoehn-Saric stepped down
as chairman in January and was replaced by
Commissioner Peter Feldman, who has been named
Acting Chairman. In a statement announcing his new
position, Commissioner Feldman said, “American
families should have condence that CPSC is hard
at work for them. Those who violate the law or import
dangerous goods from abroad should be on notice:
this Commission is focused and resolved to enforce
our statutes.”
Under Acting Chairman Feldman, the agency
is expected to maintain a strong focus on online
marketplaces. In 2024, Commissioner Feldman
and Commissioner Douglas Dziak called for an
investigation into foreign-owned e-commerce
platforms to assess compliance with the
Consumer Product Safety Act.
He was also one of two commissioners to issue a
statement related to the CPSC’s lawsuit against
a major online retailer, which centered on the
company’s responsibility to notify customers of
product recalls for items sold on its site.
It is expected that the Commission will continue
its aggressive enforcement actions under the
new Acting Chair and the new administration.
Online sellers in particular should watch for strict
oversight. Manufacturers and distributors of infant
products should also expect more scrutiny and
additional regulations.
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 25
By the numbers
In Q1 2025, there were 101 CPSC recalls, a
90.6% increase from 53 events in Q4 2024. This is
the highest quarterly total since Q1 2011 and one
of only eight since Q4 1997 to have more than 100
recalls. In contrast, the number of units recalled
fell by 43.7% from 8.24 million in Q4 to only 4.64
million this quarter. That is the lowest total in the
last 2 years. The average recall size dropped to
45,946, the lowest quarterly total in over 4 years.
Sports and Recreation accounted for the most
recalls by product category in Q1 2025, linked to
25 events each. Home Furnishings and Décor was
second with 21 events, followed by Apparel with
12 recalls.
In terms of recalled units, Yard and Garden was
the top category with 1.47 million units in Q1
2025. This was predominantly driven by a recall of
1.13 million coolers. This was the only recall this
quarter to impact more than 1 million units.
Kitchen had 923,900 units recalled, making it the
second-highest category by volume. Sports and
Recreation was the third-highest product category
in Q1 with 696,793 units recalled.
Burns and Falls were the top consumer product
hazards by event in Q1 2025, tied with 10 recalls
each. Entrapment/Strangulation was second with
nine events, followed by Fire and Injury with eight
recalls each.
Crush was the leading risk by volume, impacting
1.13 million units, primarily due to the cooler recall.
Fire was second by volume, connected to the
recall of 976,716 units. Ingestion/Burns were third
with 579,500 units involved in two separate recalls
for button cell batteries which were not in child-
resistant packaging.
As of April 1, CPSC has issued two nes for scal
year (FY) 2025 totaling $28,275,000. This is more
nes and higher penalties than all of FY 2024.
CONSUMER PRODUCTS
How recall ready are you?
As regulatory pressures intensify, it is crucial for
consumer products manufacturers and supply
chain partners to assess how prepared they are
to withstand a product incident or crisis. Sedgwick
brand protection can help with its interactive
Recall Readiness audit.
Simply answer 15 quick questions and you’ll
receive a personalized “recall readiness
score” and a detailed report featuring tailored
recommendations based on your responses.
Protect your brand and bottom line today,
visit: www.recall-ready.app.
Number of recall events by quarter
Number of recalled units by category (top 5)
Number of recall events by category (top 5)
0
Q2 2024
Q1 2024
Q4 2024
Q3 2024
Q1 2025
125
100
75
50
25
0
Furnishings
and décor
Sports and
recreation
Yard and
garden
Apparel
Children’s
products
25
20
15
10
5
0
Kitchen
Yard and
garden
Furnishings
and décor
Sports and
recreation
Apparel
1.5M
1.2M
0.9M
0.6M
0.3M
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 27
The Trump Administration’s Make America Healthy Again initiative is expected to aect
the food sector in several ways, from increased scrutiny of ingredients to updates for
nutritional guidelines. The sector may also be hit by the evolving taris since much of
the produce sold in the U.S. market is imported.
On January 15, the FDA revoked its authorization for the use of FD&C Red No. 3 in food
and ingested drugs. The change had been under review for some time and is likely the
rst in a wave of ingredient-related policy shifts. HHS Secretary Robert F. Kennedy Jr.
has been outspoken about his intent to remove articial dyes and other additives from
the U.S. food supply.
As part of this eort, Secretary Kennedy moved to close the “Generally Recognized as
Safe” (GRAS) loophole, which allows companies to self-arm new food ingredients as
GRAS. He has proposed mandatory FDA review for all new food ingredients.
In January, the FDA updated its denition of “healthy” food claims for the rst time in
more than a decade. The nal rule outlines the criteria food products must meet to carry
the “healthy” claim on their label.
That same month, the FDA released two new guidances on food allergens. The updates
aim to clarify labeling requirements, explain how the agency evaluates the public health
importance of allergens, and revise denitions across several food categories.
Stakeholders across the food industry are facing much uncertainty as the new
administration sets its priorities.
Food and drink
Dr. Martin Makary was confirmed as the next commissioner of the
U.S. Food and Drug Administration (FDA) in March. His confirmation
followed a wave of terminations at the Department of Health and
Human Services (HHS) including at least 89 members of the FDA’s
Human Foods Program and the resignation of Deputy Commissioner
of Human Foods Jim Jones.
“Food and drink manufacturers should prepare for
tighter oversight of additives as the FDA targets artificial
dyes and moves to close self-affirmed GRAS loopholes.”
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 29
Changes ahead for GRAS substances
In March, HHS Secretary Robert F. Kennedy, Jr.
directed the acting FDA commissioner to explore
potential rulemaking to revise the Substances
Generally Recognized as Safe (GRAS) Final Rule and
eliminate the self-armed GRAS pathway. Under the
current system, companies can self-arm that a new
ingredient is “generally recognized as safe” and begin
using it in food without formally notifying the FDA.
The idea of tightening regulations around GRAS food
substances is not new. The use of self-armation
has faced criticism for decades, with public health
advocates arguing that it enables the use of
potentially harmful substances without adequate
regulatory review. The Reagan-Udall Foundation’s
2022 evaluation of the FDA’s Human Foods Program
recommended routine agency assessment for
determining if ingredients could be considered GRAS.
The Federal Food, Drug, and Cosmetic Act (FD&C
Act) considers any substance that is intentionally
added to food to be a food additive and thus subject
to premarket review and approval by the FDA, unless
the substance is generally recognized as safe among
qualied experts.
The FDA strongly encourages manufacturers to
submit information about new ingredients through the
agency’s GRAS Notication Program. However, it is a
voluntary process and manufacturers can choose to
self-arm that the use of a substance is safe without
notifying the FDA.
Secretary Kennedy describes the self-armation
GRAS pathway as a “loophole that has allowed new
ingredients and chemicals, often with unknown safety
data, to be introduced into the U.S. food supply without
notication to the FDA or the public.” He wants to
require companies to publicly notify the FDA before
using new ingredients.
HHS also plans to work with Congress to explore
ways legislation can completely close the GRAS
loophole as part of the larger Make America Healthy
Again initiative.
Attorneys with Akin Gump Strauss Hauer & Feld
LLP note that eliminating the self-armation process
would signicantly increase the FDA’s workload, just
as the administration is making major cuts to the
agency’s sta.
Legal experts with Skadden Arps Slate Meagher
& Flom LLP report that the FDA spent 30 years
reviewing GRAS substances before concluding in
1997 that it lacked the time and resources to sustain
the review. That challenge remains today, as recent
reductions in sta have eliminated many of the
scientists responsible for evaluating food additives.
However, this rule change seems to be a top priority for
Secretary Kennedy, who has been a vocal supporter
of more transparency about food ingredients. Food
manufacturers should consider taking steps to provide
safety data and voluntarily notifying the FDA about
any new ingredients used in their products while the
agency works on the new rule.
Companies should also include the time for new
substance approvals in their planning. Without the
option to self-arm GRAS status, some experts
estimate that introducing new ingredients could
take several years.
Final rule for “healthy” claims issued
In December 2024, the FDA issued pre-publication
of the nal rule for human food products that updates
the denition for the implied nutrient content claim,
“healthy.” This is the rst update in more than 10 years.
Under the revised rule, for a food product to be labeled
as “healthy,” it must stay within certain limits for
saturated fat, sodium, and added sugar. It must also
contain a certain amount of food from at least one of
the ve Food Group Equivalents (FGE) established by
the Dietary Guidelines, 2020-2025: vegetables, fruits,
dairy, grains, and protein foods, which include game
meat, seafood, eggs, nuts and seeds, and beans,
peas, or lentils.
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 31
While the Dietary Guidelines do not categorize oils as a “food group,” for the purposes of
the nal rule, the FDA includes them. The agency states that oils are one of the six core
elements of a healthy dietary pattern with recommended daily intake objectives.
The rule places foods into seven categories based on their nutrient content and how they
are typically consumed. Two categories that automatically qualify as “healthy” are raw
whole fruits and vegetables and water with no added avors or ingredients.
The other ve categories are individual food products, mixed products, main dish
products, meal products, and oil products. To qualify as healthy, these foods must not
exceed established threshold limits for saturated fat, sodium, and added sugar, while
also containing specic amounts of one or more FGE, depending on the category. For
example, a main dish product must contain at least two FGEs with no less than ½ FGE
from two or more dierent food groups.
The updated “healthy” criteria also apply to related terms like “healthful,” “healthier,” and
“healthiness” when used in a nutritional context. However, the FDA chose not to regulate
terms such as “nutritious,” “wholesome,” and “good for you,” under the regulatory
denition of “healthy,” citing insucient data. Manufacturers may still use these terms,
though cautions that they can be implied nutrient content claims when they appear in a
nutritional context on a label or in labeling. Using them without sucient evidence can
lead to enforcement actions.
The rule also includes record-keeping requirements for manufacturers using the “healthy”
label, particularly when product packaging alone doesn’t prove compliance. According
to legal experts with DLA Piper, companies can choose what type of records to maintain
and are not required to use a specic form or document.
The FDA is also developing a standardized symbol to help consumers quickly identify
products that meet the “healthy” criteria.
The new rule was originally set to take eect on February 25, 2025, with a three-year
transition period before the compliance deadline of February 25, 2028. The FDA later
extended the eective date by 60 days, to April 28, 2025, to allow time for review by
the new administration. The compliance deadline remains unchanged, and no major
revisions are expected, given HHS Secretary Kennedy’s focus on food safety, nutrition,
and ingredient transparency.
Food product manufacturers should begin reviewing their labeling and nutritional content
now. While the transition period extends to 2028, early adoption of the new “healthy”
criteria is encouraged.
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 33
New guidances on food allergens
Undeclared allergens have been the leading cause of FDA food recalls
every year for the past decade. In January, the FDA released two new
guidances aimed at improving labeling and public health protections:
Questions and Answers Regarding Food Allergens, Including the Food
Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic
Act and Evaluating the Public Health Importance of Food Allergens Other
Than the Major Food Allergens Listed in the Federal Food, Drug, and
Cosmetic Act.
The Q&A publication addresses food allergen labeling requirements,
including those for tree nuts, sesame, milk, and eggs. It also oers
guidelines for incidental additives, highly rened oils, dietary supplement
products, and certain specic packaging and labeling situations, such as
individual units within a multiunit package, among other concerns.
Key updates include the position that if allergens are present unintentionally
due to cross-contact during production, they are not to be declared in
the ingredients list or the “Contains” statement. The nal guidance also
removed 11 nuts from the denition of “tree nuts,” including coconuts,
kola nuts, and chestnuts.
The FDA further claried that “milk” as a food allergen includes milk
not only from domesticated cows but also from goats, sheep, or other
ruminants. Similarly, the denition of “egg” was expanded beyond
domesticated chicken eggs to also include eggs from ducks, geese,
quail, and other fowl.
The public health guidance outlines how the FDA plans to assess the
public health importance of food allergens not among the nine major
food allergens identied under U.S. law. The FDA states that it is open
to considering non-listed food allergens on a case-by-case basis if public
health concerns arise. The guidance primarily outlines the scientic criteria
the agency will use to make these evaluations.
Although these guidances are not legally binding, food manufacturers
should review them carefully to determine whether labeling updates are
needed. Companies should also assess their risk and crisis management
plans to ensure they align with the FDA’s evolving expectations to avoid
potential enforcement actions.
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 35
The number of FDA food recalls decreased by 3.8%
in Q1 2025 compared to Q4 2024, falling to 127
events. In contrast, the number of impacted units
rose by 232.1%, increasing from 21.15 million last
quarter to 70.25 million this quarter. This was the
highest quarterly total in the past seven quarters.
There were four recalls that aected more than two
million units, including one for prepared chocolate
shakes that involved 57.24 million units.
Undeclared allergens remained the leading cause
of FDA food recalls for another quarter with 50
events in Q1 2025. Milk was the most common
allergen and was cited in 18 recalls, followed by
nuts with 8 recalls. Bacterial contamination was
the second-highest cause of FDA food recalls in
Q1 in terms of events with 29, down from 39 in Q4.
Foreign materials was third with 23 recalls.
Bacterial contamination impacted 59.65 million
units, the most of any hazard in Q1. Foreign
materials were second with 5.05 million units
recalled. Choking hazards were third with 3.10
million units linked to a single recall of baby
teething sticks.
Prepared Foods experienced the most recalls of
any product category in Q1 2025 with 39 events.
Produce was second with 21 events. Flavorings
were third with 15 recalls, including two incidents
involving excessive lead levels.
In terms of units impacted in Q1, Supplements led
with 57.54 million, primarily due to the chocolate
shake recall. Prepared Foods were second by
volume with 8.45 million units recalled. Baked
Goods were third with 2.05 million units impacted,
largely due to a recall of assorted donuts and
cakes for Listeria concerns.
FDA FOOD AND BEVERAGE
By the numbers
How recall ready are you?
As regulatory pressures intensify, it is crucial for
food and drink manufacturers and supply chain
partners to assess how prepared they are to
withstand a product incident or crisis. Sedgwick
brand protection can help with its interactive
Recall Readiness audit.
Simply answer 15 quick questions and you’ll
receive a personalized “recall readiness
score” and a detailed report featuring tailored
recommendations based on your responses.
Protect your brand and bottom line today,
visit: www.recall-ready.app.
Number of recall events by quarter
Number of recalled units by category (top 5)
Number of recall events by category (top 5)
90
Q2 2024
Q1 2024
Q4 2024
Q3 2024
Q1 2025
140
130
120
110
100
0
Produce
Prepared
foods
Baked
goods
Flavoring
Supplements
50
40
30
20
10
0
Prepared
foods
Supplements
Candies
Baked
goods
Produce
60.0M
10.0M
7.5M
5.0M
2.5M
~
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 37
In Q1 2025, the number of USDA food recalls
rose by 28.6% to nine events, compared
to seven recalls in Q4 2024. For context,
only 5 quarters over the past 10 years have
experienced a lower number of recall events.
However, the number of units impacted dropped
by 96.5% from 12.02 million pounds last quarter
to 425,317 pounds this quarter.
The top reasons for USDA recalls by event
were foreign materials and the combination
of misbranding and undeclared allergens with
three recalls each. Non-bacterial contamination,
no inspection, and ineligible to import had one
event each.
By unit count, non-bacterial contamination
was the leading cause of USDA food recalls,
impacting 212,268 pounds in Q1. This was
linked to a single recall of liquid eggs that
contained sodium hypochlorite. The combination
of misbranding and undeclared allergens was
second by volume this quarter, tied to 105,867
pounds of recalled product. Foreign material
was third with 72,131 pounds aected.
Poultry had four recalls in Q1 2025, up slightly
from the 3 poultry recalls from the previous
quarter. Pork and beef each had two events and
sh had one. There have only been 4 sh recalls
announced by the USDA in the past 13 years.
Poultry was responsible for the most units
recalled by product category with 342,605
pounds aected in Q1 2025—62.0% of which
were attributable to the single recall for sodium
hypochlorite contamination in liquid eggs, noted
above. Beef was second with 63,440 pounds
impacted, followed by pork with 18,120 pounds.
USDA FOOD AND BEVERAGE
By the numbers
How recall ready are you?
As regulatory pressures intensify, it is crucial for
food and drink manufacturers and supply chain
partners to assess how prepared they are to
withstand a product incident or crisis. Sedgwick
brand protection can help with its interactive
Recall Readiness audit.
Simply answer 15 quick questions and you’ll
receive a personalized “recall readiness
score” and a detailed report featuring tailored
recommendations based on your responses.
Protect your brand and bottom line today,
visit: www.recall-ready.app.
Number of recall events by quarter
Number pounds recalled by category (top 5)
Number of pounds recalled by quarter
0
Q2 2024
Q1 2024
Q4 2024
Q3 2024
Q1 2025
15
12
9
6
3
0
12M
10M
8M
6M
4M
0
Misbranding
and undeclared
allergen
Non-bacterial
contamination
No inspection
Foreign
material
Ineligible
to export
250K
200K
150K
100K
50K
Q2 2024
Q1 2024
Q4 2024
Q3 2024
Q1 2025
2M
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 39
In his rst speech to HHS sta, Secretary Kennedy noted
some of the issues he would like the agency to prioritize for
the food sector, including glyphosate and other pesticides,
ultra-processed foods, articial food allergies, PFAS and
PFOAs, and microplastics. The secretary stated he would
like to “subject them all to the scrutiny of unbiased science.”
Secretary Kennedy is also leading the Make America
Healthy Again (MAHA) Commission, whose goal is to lower
the rate of chronic disease in the U.S. and end childhood
chronic disease. The Commission, which is composed
of representatives from multiple federal agencies, will
re-think policy on a range of topics, including nutrition,
healthy lifestyles, and food quality and safety. It is tasked
with issuing an assessment to President Trump in May
2025 and a more fulsome strategy in August 2025 on how
it will achieve its objectives. The MAHA Commission’s
recommendations could impact multiple sectors.
In March 2025, Secretary Kennedy took the rst step
in reforming the regulation of ultra-processed foods by
directing FDA to revise the GRAS (Generally Recognized
as Safe) Final Rule. Currently, the FDA maintains a GRAS
Notication Program that includes a public inventory of
GRAS notices. However, the program does not account for
all the food ingredients that enter the market through the
self-armation process, or “the GRAS loophole.”
The companies themselves are responsible for determining
whether a substance is GRAS or whether it requires a
pre-market submission to the FDA as a food additive. They
conduct their own safety review to establish GRAS status
for new substances, engaging their own panel of scientic
experts without other regulatory oversight. Based on their
research, companies can self-arm an ingredient as GRAS
without notifying the FDA.
If a manufacturer fails to conduct the scientic review
required to establish a substance as GRAS or does not
submit a non-GRAS substance to FDA for review as a new
food additive, then the substance is considered an unlawful
food additive subject to enforcement action.
Under the proposed changes, companies would be
required to notify the FDA and provide safety data before
they are permitted to introduce a new food ingredient into
the food supply. It would take away companies’ authority
to self-arm an ingredient.
The first quarter of 2025 saw significant changes for food regulation
with the confirmation of Robert F. Kennedy Jr. as Secretary of Health
and Human Services (HHS) and of Dr. Martin Makary as Food and Drug
Administration (FDA) Commissioner.
Food policy priorities for
the new administration
RACHEL TUROW, SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP
Secretary Kennedy stated in a Fox News interview that his
goal is for every food ingredient, even those currently on the
market, to be reviewed and many of them removed from the
food supply, indicating a sweeping reform of GRAS.
Tightening the standards for GRAS designation and
subjecting more additives to the premarket review process
would increase oversight for new food additives. The FDA
previously undertook a 30-year comprehensive review of
all GRAS food substances and concluded in 1997 it was
not able to sustain the review due to time and resource
constraints within the agency.
Major GRAS reform that requires premarket review of
the majority of food ingredients, rather than the small
minority currently subject to premarket review, would likely
overwhelm FDA resources as it did during the prior review.
It is unclear if the FDA will recommend a retrospective
review of food additives that have already been marketed
as GRAS or only implement changes for ingredients
moving forward. Secretary Kennedy’s remarks indicate
a comprehensive review is likely. An assessment of that
scale would stretch agency resources even more at a time
when the current administration is making major cuts to all
federal agencies, including the FDA.
While we have not yet seen an uptick in Warning Letters,
food additive revocations, or other enforcement actions
from the FDA, it is likely that an enforcement eort will
accompany regulatory reform.
Another top priority for Secretary Kennedy is eliminating
articial food dyes. In April 2025, Secretary Kennedy
announced that FDA is taking actions to remove petroleum-
based dyes from the U.S. food supply. FDA committed to
the following actions:
• Starting the process to remove authorization for Citrus
Red No. 2 and Orange B, which are used to color
orange peels and sausage casings, respectively.
• Creating a public timeline for food manufacturers to
voluntarily transition from petrochemical-based dyes to
natural alternatives, including voluntarily eliminating six
synthetic dyes—FD&C Green No. 3, FD&C Red No. 40,
FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No.
1, and FD&C Blue No. 2—from the food supply by the
end of 2026.
• Authorizing four new natural color additives that can be
used in place of the synthetic dyes.
• Expediting the timeline for food companies to remove
FD&C Red No. 3 from products from food products. The
previous deadline was 2027-2028, but FDA may modify
its order to expedite removal.
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 41
Petroleum-based dyes have already been banned by
certain states. In particular, West Virginia and California
have enacted laws banning the use of seven dyes and
two preservatives by January 1, 2028: red dyes No. 3
and No. 40, yellow dyes No. 5 and No. 6, blue dyes No.
1 and No. 2, green dye No. 3, butylated hydroxyanisole,
and propylparaben in foods served in public schools.
Given these state-level bans, companies had already
been working to reformulate. However, federal action on
an expedited timeline may require more rapid work to nd
alternative ingredients.
The FDA’s new Commissioner, Marty Makary, has joined the
agency when there is signicant focus on ultra-processed
foods. The Human Foods Program (HFP) at the FDA is
still in its infancy having been formalized in October 2024.
While nutrition and food safety are clear priorities for HHS
Secretary Kennedy, the HFP was a target of stang cuts
and the previous Deputy Commissioner resigned earlier this
year. There is currently an Acting Deputy Commissioner for
Human Foods who may be made permanent.
When promoting his new book, Blind Spots: When Medicine
Gets It Wrong, and What It Means for Our Health, Dr.
Makary spoke publicly about his belief that many negative
health outcomes are linked to diet, and that drugs are only
one part of overall medical treatment and a healthy lifestyle.
Like his boss, Secretary Kennedy, he has been a vocal critic
of ultra-processed foods. It would not be surprising to see
Dr. Makary working closely with the MAHA Commission to
implement recommendations around ultra-processed foods
and emphasizing the FDA’s role in reviewing and approving
food additives.
There are several other major food policy initiatives
under the new administration. One of these is nutrition
labeling reform. At the end of the last administration, the
FDA introduced a proposed rule on front-of-pack nutrition
labeling, which may have been in anticipation of an
incoming HHS secretary with a focus on nutrition. We likely
will see this rule nalized, perhaps with a shorter than usual
implementation window for the industry.
Another focus is the coordination with other agencies
to limit consumption of ultra-processed foods. The U.S.
Department of Agriculture (USDA) runs the Women, Infants,
and Children (WIC) program, as well as the Supplemental
Nutrition Assistance Program (SNAP), aimed at expanding
access to food for people living under federal poverty limits.
Only certain foods are eligible for purchase using WIC
and SNAP, and some of the foods may not meet MAHA
standards. A coordinated eort between the FDA and
USDA could limit billions of federal dollars spent on ultra-
processed foods. This might also entail additional labeling
changes and nutritional standards for these programs. We
are also seeing a reduction in ultra-processed foods in
school lunches.
The Operation Stork Speed initiative was announced by
HHS in March 2025. It focuses on improving ingredients
in and transparency of labeling related to infant formula.
The U.S. has not done a formal review of infant formula
ingredients since 1998. Under Operation Stork Speed,
the FDA will require better formula labels, increase testing
for heavy metals, allow more personal importation of
foreign-made formula, and conduct health outcomes
research related to formula consumption. The initiative also
encourages innovation and new sources of U.S.-based
formula manufacturing.
A fourth priority is launching the Chemical Contaminants
Transparency (CCT) tool, which the FDA released on
March 20. The tool is a searchable database that provides
a consolidated list of contaminant levels that are used to
evaluate potential health risks of contaminants in human
foods. Examples of these levels are tolerances, action
levels, and guidance levels. The database includes a broad
range of chemical substances that may be present in food so
consumers can assess what is in the foods they are eating.
More than any other product category regulated by the
FDA, the food sector may see the most sweeping regulatory
changes under the new administration. Food manufacturers
should be ready for additional scrutiny and unexpected
approaches to regulation.
RACHEL TUROW, SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP
CONTINUED FROM PREVIOUS PAGE
The views expressed in this article are those of the author
and do not necessarily reflect the opinions of Sedgwick.
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 43
The FDA continues to focus on data integrity for medical devices. In March, the agency
published a notication warning about the increase in unreliable data from third-party
testing facilities. It also posted a letter it sent to a third-party lab, stating it would no longer
accept data from its tests as part of a marketing authorization submission. Going forward
it appears that such letters will be made public, allowing study sponsors and device
manufacturers to avoid disreputable facilities.
The Trump Administration is focused on managing and preventing chronic illnesses. The
FDA’s new Home as a Health Care Hub initiative is designed to integrate the use of medical
devices in home-based care to improve health outcomes. This could be an important tool
for managing chronic conditions. The FDA also hopes to spark more innovation in the
development of new devices or novel uses of current devices.
The FDA is promoting a total product life cycle (TPLC) approach to medical devices that
integrate AI-enabled software functions. The agency published a new guidance with
suggestions on what to include in marketing submissions for these types of products.
Medical device manufacturers will be watching to see which issues are most important for
President Trump and Secretary of Health and Human Services Robert F. Kennedy Jr. Data
integrity and chronic disease management are emerging as clear themes, and stakeholders
should expect more action throughout 2025.
Medical device
On March 31, a federal judge vacated the U.S. Food and Drug
Administration’s (FDA’s) Laboratory-Developed Test (LDT) rule,
stating that the agency did not have the statutory authority
to regulate LDT services and the final rule exceeded the FDA’s
authority. In his order, the judge noted that the FDA projected
the total costs associated with the regulation would range from
$12.57 billion to $78.99 billion over the next 20 years.
“Following a major court ruling on LDT oversight,
manufacturers should reassess compliance strategies
amid shifting FDA authority and enforcement boundaries.”
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 45
FDA focuses on data integrity
The FDA has increasingly warned medical device
manufacturers and sponsors of device studies
about fraudulent third-party data. In March 2025, the
agency posted a notication about medical device
data integrity on a new dedicated webpage. It stated
that the Center for Devices and Radiological Health
(CDRH) “is vigilant in ensuring data submitted to the
FDA can be relied upon to assess the eectiveness,
safety, or risk of a device.”
The FDA reported a rise in third-party testing facilities
supplying unreliable testing data. This issue has
made it harder for the agency to reach a “substantial
equivalence determination” or issue marketing
authorizations for medical devices that include
questionable data in their submissions.
In its statement, the FDA raised concerns about the
negative impact faulty data has not only on medical
device sponsors, but also on patients and healthcare
providers, whose access to new devices may be
delayed or reduced.
In addition to the notication, the FDA posted a
General Correspondence Letter (GCL) that it had
sent to a testing lab on February 26, 2025. The letter
alleged that the facility had, in multiple instances,
“copied the results of another study or created falsied
or otherwise invalid data that was submitted to the
FDA.” It also stated that “all study data from all studies
conducted at this testing facility will be rejected” until
the agency’s concerns are fully resolved.
According to attorneys with Akin Gump Strauss Hauer
& Feld LLP, prior to the new notication and dedicated
webpage, it was unclear which testing labs were
the targets of the FDA’s concerns. The legal experts
noted that although the FDA can take action against
fraudulent labs and reject their data, those actions
aren’t always made public. This lack of information
can leave sponsors at risk of unknowingly working
with questionable facilities.
By publicly posting the GCLs related to data integrity,
the FDA is increasing transparency and providing a
valuable resource for sponsors and manufacturers to
vet third-party labs.
The FDA issued another alert in March, reporting that
after testing 95 acne products containing benzoyl
peroxide for possible benzene contamination, more
than 90% had undetectable or extremely low levels of
benzene. This directly contradicted earlier third-party lab
claims of elevated benzene in many of these products.
Several voluntary product recalls followed the release
of the initial third-party data. However, the FDA’s
own evaluation found that only six of the 95 products
tested had elevated benzene levels. In its statement,
the agency stressed that it is critical that third-party
laboratories use validated testing methods if they are
sharing results with consumers.
Looking ahead, third-party testing laboratories should
expect continued scrutiny of their data. Medical device
study sponsors and product manufacturers should
carefully assess any third-party providers, especially
those conducting safety, performance, or cybersecurity
testing. They should also independently verify all
testing results before submitting data to the FDA.
CDRH launches Idea Lab to promote
use of medical devices at home
The FDA has been promoting the use of medical
devices for remote care with its recent guidance
on decentralized clinical trials. As part of this eort,
the CDRH has launched an Idea Lab under its
Home as a Health Care Hub program. The goal is
to reimagine patients’ homes as a vital part of their
health care system.
The agency recognizes that while many medical
devices are used in home settings, most of them
were designed to work independently rather than
within an integrated, holistic environment. The Idea
Lab encourages innovation in home-use of medical
devices to promote diverse perspectives, new
concepts, and more holistic approaches to home care.
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 47
1
The new concept oers developers free tools to help
“identify challenges, constraints and opportunities for
people navigating their medical conditions in their daily
lives.” It includes a virtual reality prototype called the
Lilypad™ which can be used to conceptualize and
integrate solutions. The vision is to develop new home-
use devices and nd ways to adapt existing medical
devices to function better in home environments.
The rst Lilypad test case oers an immersive
experience to explore several aordable homes of
representative people living with diabetes. Diabetes
was selected due to the prevalence of this condition.
The CDC’s National Diabetes Statistics Report
estimates that 38 million people in the United States,
or 11.6% of the population, have diabetes. The FDA
recognizes the burden of living with this condition and
the important role medical devices and lifestyle play
in managing the disease and preventing other serious
health complications, including blindness, kidney
failure, and heart disease.
While the rst test case is diabetes, the FDA has stated
that the Health Care Hub initiative was developed to
start conversations about prevention, wellness, and
management of many chronic diseases. This goal
aligns with the MAHA campaign’s focus on lowering
the rates of chronic illness in the U.S.
Medical device companies should follow the
development of the Idea Lab and other projects
under the Home as a Health Care Hub program for
opportunities to oer insights. They should also monitor
the platform for information and research to guide
product improvements.
New guidance for AI-enabled
medical devices
In January, the FDA issued a draft guidance regarding
life cycle management and marketing submissions for
AI-enabled functions of medical device software. The
document also oers medical device manufacturers
and study sponsors specic recommendations for
their marketing submissions for this type of device.
Attorneys with Greenberg Traurig, LLP note that the
document focuses on the FDA’s holistic total product
life cycle (TPLC) approach, which considers oversight
of a medical device across three dierent phases:
design and development, which integrates risk
management; validation and testing across a range
of patient populations and setting, and post-market
performance monitoring.
The guidance also emphasizes the need for
transparency from manufacturers and bias mitigation
when integrating AI into their devices. The FDA
oers standards for transparency, accountability,
and exibility as companies manage their AI-enabled
devices across the TPLC.
The nal guidance will include information about
the recommended documentation and information
that sponsors and manufacturers should provide in
marketing submissions if their device has one or more
AI-enabled software functions.
Examples of critical elements include the following:
a clear, comprehensive device description; user
interface information; labeling to explain how AI is
used, model inputs and outputs, any automated
functions, performance data and metrics, instructions
for use, and training and testing data.
The FDA recommends companies include
performance validation data to demonstrate accuracy,
reliability, and repeatability. Submissions should
also include relevant change management plans, a
risk management plan, and robust assessments to
evaluate the risks and impact of AI functions.
Other considerations include information about
cybersecurity and data integrity measures and a
public submission summary that details the AI-
enabled device’s characteristics for use in public
facing documents.
The public comment period closed on April 7. Medical
device companies should monitor the FDA website for
updates on submitted feedback and the timeline for nal
guidance. In the meantime, they should also review the
draft recommendations and consider adopting these
best practices in upcoming marketing authorizations.
The legal experts caution that since the new
administration has rolled back some AI measures initiated
by the Biden Administration, there may be additional
changes or delays for future actions on this guidance.
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 49
By the numbers
In Q1 2025, the number of medical device recalls
fell by 8.9% compared to Q4 2024, decreasing
from 259 events to 236. There were 18.58 million
units recalled this quarter, a drop of 42.1%
compared to last quarter. This is the lowest
quarterly total recorded in the past 3 years, and
the third-lowest gure in the past 8 years.
Device failure was the leading cause of medical
device recalls in Q1 2025, accounting for 48
events. Software was the second-most common
concern with 31 events, followed by mislabeling
with 24 recalls.
Safety concerns were responsible for the most
units recalled this quarter with 7.97 million,
primarily linked to one recall of 6.22 million
sampling lines and airway adapters and another
recall involving 1.17 million assorted medical
tools. The second-most common reason for
medical device recalls by volume was device
failure, with 3.65 million units impacted. Sterility
had the third-highest number of units recalled
with 1.37 million.
The number of Class II and Class III medical
device recalls decreased in Q1 2025. However,
Class I recalls rose quarter-over-quarter from 25
to 31. Only one quarter in the past 20 years has
recorded more Class I recall designations (Q1
2024 with 33).
The number of units impacted fell across all
three categories compared to Q4 2024. The
biggest decrease by percentage was for Class
III units, which fell by 95.7%. Class I and Class II
units dropped by 57.7% and 40.9%, respectively.
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Number of recall events by quarter
Number of recalled units by category (top 5)
Number of recall events by category (top 5)
200
Q2 2024
Q1 2024
Q4 2024
Q3 2024
Q1 2025
300
280
260
240
220
0
Software
Device
failure
Safety
Mislabeling
Parts issue
50
40
30
20
10
0
Device
failure
Safety
User error
Sterility
Packaging
defect
10M
8M
6M
4M
2M
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 51
Notable device safety challenges and risks
In 2024, the FDA’s recall process faced increased scrutiny
following a steady rise in annual Class I recalls which hit
a 15-year high last year. This category represents the
most serious circumstances where there is a reasonable
probability the defective device will cause serious adverse
health consequences or death.
Perhaps most notable Class I recall in 2024 involved a
leading manufacturer who recalled more than 15 million
respiratory devices and the subsequent U.S. Government
Accountability Oce’s inquiry into FDA’s oversight of
medical device recalls.
In April 2024, the device manufacturer entered a consent
decree with the Department of Justice and agreed to
stop selling certain respiratory machines in the U.S. The
decree also required the company to implement a Recall
Remediation Plan. In November 2024, the FDA’s Centers
for Device and Radiological Health (CDRH) launched a
pilot program to speed up public communications regarding
“high-risk” recalls and enhance their medical device
recall program.
Overall, medical device recall events reached a four-year
high in 2024, increasing 8.6% to 1,059 events compared
to 975 recalls in 2023. The top recall causes were device
failure, quality, software, mislabeling, and parts issues.
Several device failure recalls in 2024 were also connected
to software functionality errors—particularly those involved
with life-sustaining or critical operations. In addition,
several recalls were due to device manufacturers failing
to meet sterility requirements, which often arise from a
lack of adequate quality control processes or potential
contamination during the manufacturing process.
Finally, some mislabeling recalls, especially for devices
intended for the home use environment where patients
or caregivers may not have sucient training, were tied
to unclear or inadequate instructions for use that resulted
in improper device usage.
One important source that can help identify early signs
of safety concerns, risks, and challenges associated with
medical devices is the FDA’s Manufacturer and User
Facility Device Experience (MAUDE) database. The tool
is publicly accessible and houses both voluntary medical
device reports and mandatory reports submitted to the FDA
by manufacturers, importers, and device user facilities.
A February 2025 study concluded that “[n]early a third of
manufacturer reports of medical device adverse events
were not demonstrably submitted to the FDA within the
regulatory deadline” and that “[l]ate adverse event reporting
may prevent early detection of patient safety concerns.”
Absent changes to the FDA’s enforcement approach for
timely reporting, we expect this trend to continue for the
foreseeable future and are eager to see if the FDA provides
further guidance on this topic.
While the U.S. Food and Drug Administration (FDA) continued to push for
more strategic product guidance and guidelines in 2024, it also implemented
organizational changes and enhanced existing quality and postmarket programs.
A look back at 2024 FDA actions
BRIGID BONDOC AND ATIQ CHOWDHURY (MORRISON & FOERSTER
LLP), AND GEORGE KWIECINSKI (GLOBAL KEY SOLUTIONS)
Preparing for device challenges and risks
Where possible, particularly for novel premarket
submissions and those involving devices with articial
intelligence and machine learning (AI/ML) software
functionality, manufacturers should engage and collaborate
early with the FDA to better understand a device’s risk
prole and potential challenges. Device manufacturers
should proactively identify issues and areas of concern in
their submissions and solicit feedback from the FDA though
the Q-Submission process and other channels.
Separately, device manufacturers should ensure they
continue to meet the FDA’s Medical Device Reporting (21
CFR Part 803) and Reports for Corrections and Removals
(21 CFR Part 806) requirements and deadlines. Timely
submissions may build credibility with the agency and
help avoid additional FDA scrutiny.
Device manufacturers should also develop a robust
Quality Management System (QMS) that includes thorough
design validation testing and inspection and root-cause
investigation processes to help identify and prevent
potential device failure issues that could lead to a recall.
Establishing an adequate risk management le is pertinent.
This includes documenting product risk assessments
that are periodically reviewed internally, which can help
identify and address emerging risks. Additionally, with the
FDA’s recent and heightened focus on medical device
cybersecurity, device manufacturers should implement
strong cybersecurity controls and a plan for addressing
postmarket cybersecurity vulnerabilities such as data
breaches and unauthorized access.
Device manufacturers should also conduct periodic internal
audits to ensure compliance with FDA regulations and
guidance. In addition, instituting a recall readiness plan can
conrm that systems are in place to detect and address
potential device safety issues. A robust plan will also allow
manufacturers to communicate eectively with regulatory
bodies, customers, and patients.
Finally, device manufacturers are encouraged to provide
public comments on any recent FDA draft guidance
documents, such as the publication on Articial Intelligence-
Enabled Device Software Functions: Lifecycle Management
and Marketing Submission Recommendations. Having their
voice heard can help raise issues that the agency may not
have considered before a new rule advances too far.
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 53
Changes or evolving recall landscape
In November 2024, based on commitments noted in the
Agency’s 2024 Safety Report and recommendations from
the Patient Engagement Advisory Committee, CDRH
announced a Recall Communications Pilot Program. The
goal is to improve the timeliness of communications from
companies about corrective actions the FDA believes are
likely to be “high-risk recalls.” The agency specied “[t]hese
actions may include when companies remove products from
the market, correct products, or update instructions
for using products due to potentially high safety risks.”
The FDA issued its rst early alert as part of this pilot
program on an infusion pump recall in December 2024.
Later that month, the FDA notied the public of safety issues
involving medical devices from four other manufacturers.
The program also highlights the importance of maintaining
compliance with device reporting obligations. The measure
aligns with a recent trend from the FDA of placing
more responsibility on device manufacturers to provide
information and education to health care providers and
patients throughout a product’s total life cycle.
From 2019 to 2023, the number of postmarket warning
letters issued by CDRH and the FDA has steadily increased.
This trend is expected to continue. Top warning letter
violations included Corrective and Preventive Action (21
CFR 820.100(a)) and Complaint Files (21 CFR 820.198(a)).
The frequency of warnings around these topics emphasizes
the need for medical device manufacturers to strengthen
compliance frameworks, particularly in quality systems and
proactive issue investigation and remediation controls.
The FDA underwent a large reorganization which took eect
October 1, 2024. It included the creation of the Oce of
Inspections and Investigations (OII), with more than 8,000
employees across various oces, including CDRH, moving
to the new department. The Oce of Medical Device and
Radiological Health Inspectorate (OMDRHI) is an oce
within the Medical Products Inspectorate (MPI) that now
sits under OII.
The FDA states that “the reorganization will enable the FDA
to be more ecient, nimble and prepared for the ever-
changing and complex industries we regulate, new food
and medical product technologies, as well as the impacts of
globalization, climate change and other factors that require
the agency to quickly adapt.”
Future developments
Looking forward, the 2024 CDRH Safety Report stressed
the importance of ensuring devices on the U.S. market
are high-quality, safe, and eective and remain so over
time. The report suggested implementing three actions
towards that end: advancing improved device quality such
as using AI tools to better track and identify quality issues;
strengthening active surveillance, including leveraging real-
world evidence; and enhancing the medical device recall
program, which may include steps to reduce time for public
recall notications and enhanced tracking for the MAUDE
database and medical device reporting.
The 2024 CDRH Innovation Report further highlights certain
actions FDA intends to implement over the next year. For
example, FDA plans to continue modernizing the premarket
review process, support early engagement between them
and developers, and work with developers and providers
to facilitate the innovation of new home-use devices. As
a result, device manufacturers should strategically review
and enhance their existing QMS policies and controls,
emphasizing increased scrutiny on software validation, AI/ML
software functionalities, and overall cybersecurity controls to
proactively align with emerging compliance expectations.
It is worth noting that many of these plans were developed
during the previous administration. With a new Secretary of
Health and Human Services and a new FDA Commissioner,
priorities are likely to shift.
BRIGID BONDOC AND ATIQ CHOWDHURY (MORRISON & FOERSTER LLP),
AND GEORGE KWIECINSKI (GLOBAL KEY SOLUTIONS)
CONTINUED FROM PREVIOUS PAGE
The views expressed in this article are those of the author
and do not necessarily reflect the opinions of Sedgwick.
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 55
These measures include the launch of the Make America Healthy Again (MAHA) initiative,
which will focus on combating chronic health conditions for Americans, especially children.
The MAHA Commission will assess a range of potential causes for disease, such as the
prevalence of and threat posed by certain drugs, food additives, and other chemicals.
Federal funding for pharmaceutical research may be aected by the Commission’s ndings,
with the potential of funds to be cut or reallocated.
Secretary Kennedy also rescinded a policy known as the Richardson Waiver related to the
Administrative Procedure Act. The change means that now federal rules relating to public
property, loans, grants, benets, or contracts are no longer required to have a notice and
comment period to allow public input on rulemaking. While supporters say this will allow
HHS to be more nimble when making changes to rules, opponents caution that the lack
of transparency around contracts and grant funding is not in the public interest.
In January, the FDA issued guidance to help pharmaceutical manufacturers ensure batch
uniformity and drug product integrity by complying with current good manufacturing practice
(cGMP). In 2024, the majority of recalled pharmaceutical units were due to cGMP deviations.
The FDA removed two popular glucagon-like peptide 1 (GLP-1) medications from the drug
shortage list in the rst quarter of 2025, which means compounding pharmacies will no
longer be authorized to manufacture them. Branded manufacturers had been warning
about the use of compounded versions of their products, citing concerns over patient
safety, inconsistent dosing, and lack of oversight in compounding practices.
Another uncertainty for the industry is the threat of taris on imported pharmaceuticals by
the new administration. This could put signicant pressure on U.S.-based manufacturing
facilities to meet demand. It is unclear if more shortages, at least in the short term, will
result. Pharmaceutical manufacturers and suppliers should monitor policy changes closely
and begin planning for multiple scenarios.
Pharmaceutical
The first quarter of 2025 kicked off under a new administration with
the Republican party in control of the House, Senate, and White
House. The new Secretary of Health and Human Services (HHS),
Robert F. Kennedy Jr., and President Trump introduced several
actions that will impact the pharmaceutical industry.
“Given the FDA’s renewed focus on cGMP violations,
manufacturers must prioritize batch uniformity
and process controls to avoid costly recalls.”
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 57
Make America Healthy Again
Commission launched
In February, President Trump signed an Executive
Order (EO) to establish the President’s Make America
Healthy Again (MAHA) Commission with the goal
of understanding and dramatically lowering chronic
disease rates in both adults and children.
The MAHA Commission is led by HHS Secretary
Robert F. Kennedy Jr. and is comprised of
representatives from a wide range of departments
and agencies. These include the Departments of
Agriculture, Housing and Urban Development,
Education, and Veterans Aairs, the Environmental
Protection Agency, the Oce of Management and
Budget (OMB), the Centers for Disease Control and
Prevention (CDC), and the National Institutes of
Health (NIH).
The group is tasked with studying the potential
contributing causes of childhood chronic disease,
including “the American diet, absorption of toxic
material, medical treatments, lifestyle, environmental
factors, government policies, food production
techniques, electromagnetic radiation, and corporate
inuence or cronyism.”
The Commission has been given 100 days to conduct
and submit to the president a “Make Our Children
Healthy Again Assessment,” which will include the
identication and description of childhood chronic
disease in America compared to other countries; an
evaluation of the potential over-utilization of medication,
certain food ingredients, and chemicals; and an
assessment of the prevalence of and threat posed by
the prescription of selective serotonin reuptake inhibitors
(SSRIs), antipsychotics, mood stabilizers, stimulants,
and weight loss drugs. The report should also examine
best practices for preventing childhood health issues—
including proper nutrition, steps to eliminate undue
industry inuence on science, and the establishment
of a framework for transparency and ethics review in
industry-funded projects.
Within 180 days, the MAHA Commission must oer
a strategy based on its “Make Our Children Healthy
Again Assessment,” which could restructure the federal
government’s response to childhood chronic disease.
Lawyers with DLA Piper caution that the EO could
have a signicant impact on many businesses in
the life sciences, healthcare, and food sectors. For
example, the legal experts predict increased scrutiny
on the use of prescription medicines to treat chronic
disease, cognitive dierences, and mental health
conditions; adjustments to how federal funding for
research into pharmaceuticals is distributed; more
funding for research on alternative medicine or
natural remedies; and stricter requirements for
data transparency in the public and private sectors.
Other possible changes include adjustments to the
CDC’s Advisory Committee on Immunization Practices
and other actions that could restrict vaccines or
otherwise decrease federal government support of
vaccines. This is particularly likely given Secretary
Kennedy’s previous statements about vaccines.
Pharmaceutical manufacturers should prepare for
increased scrutiny and ensure they have strong
scientic support for any claims about their products.
HHS ends public notice and comment
period for rulemaking
In March, HHS Secretary Robert F. Kennedy Jr.
issued a statement ending a long-standing policy
under the Administrative Procedure Act (APA) for
certain rules relating to public property, loans, grants,
benets, or contracts.
According to the APA, federal agencies are required
to issue a notice of proposed rulemaking in the
Federal Register and provide stakeholders the
opportunity to comment on proposals for new or
amended rules before the agency issues a nal rule.
Under the APA, rules relating to public property, loans,
grants, benets, or contracts are exempt from the
notice and comment requirements.
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 59
However, in 1971, HHS established a policy on Public Participation in Rule
Making called “the Richardson Waiver” which waived the exception from the
notice and comment period for public property, loans, grants, benets, or contracts
rulemaking. For more than 50 years, a notice and comment period has typically
been included with rulemaking even for these issues.
Lawyers with Morgan Lewis & Bockius LLP note that with the waiver rescinded,
HHS can now make changes related to its programs that provide loans, grants,
benets, or contracts with “less public awareness and input, and with much greater
speed and eciency.”
The attorneys estimate that HHS is the largest grant-making agency in the U.S. It
oversees approximately 100 programs across its operating divisions, which include
the National Institutes of Health (NIH), the U.S. Food and Drug Administration
(FDA), Medicare and Medicaid regulated by the Centers for Medicare & Medicaid
Services (CMS), and the Centers for Disease Control (CDC), as well as social
service programs such as the Supplemental Nutrition Assistance Program (SNAP)
and Head Start.
With the Trump Administration’s focus on cuts to social programs, some have
raised concerns that by eliminating the notice and comment period, it will be easy
to make big changes to programs such as Medicare. The legal experts note that
a 2019 U.S. Supreme Court decision requires the CMS to engage in notice and
comment rulemaking when Medicare policies or guidance change or establish
a substantive legal standard.
However, lawyers with Akerman LLP urge government contractors and other
stakeholders to follow how HHS uses its new expedited rulemaking policy and be
prepared for potentially rapid changes to rules relating to government contracts.
They predict that there may be a rise in legal action or lobbying Congress if
stakeholders are negatively impacted by the new policy.
New guidance issued on cGMP requirements
Deviations from current good manufacturing practice (cGMP) requirements led to
the recall of 16.90 million pharmaceutical units in 2024, accounting for 40.7% of
all recalled products in the sector. In January, the FDA issued a guidance and call
for public comment regarding considerations for complying with the requirements
in 21 CFR 211.110. This section of the Code of Federal Regulations focuses on
ensuring batch uniformity and drug product integrity for pharmaceuticals.
The guidance examines quality considerations for drug products produced using
advanced manufacturing and explores how manufacturers can incorporate
process models into commercial manufacturing control strategies.
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 61
The FDA describes “advanced manufacturing” as “an innovative pharmaceutical
manufacturing technology or approach that has the potential to improve the reliability
and robustness of the manufacturing process and supply chain and increase timely
access to quality medicines for the American public.” This can include 3D printing and
continuous manufacturing and the integration of novel technological approaches, the use
of established techniques in an innovative way, or the application of production methods
in a new domain where there is limited experience or no dened best practices.
Attorneys with Arnold & Porter highlighted the general considerations for in-process
sampling and testing laid out in the guidance, stating that the FDA urges manufacturers
to use a scientic and risk-based approach that outlines “what, where, when, and how
in-process controls, and tests, or examinations should be conducted on samples of in-
process material.”
The guidelines recommend that manufacturers “identify which critical quality attributes
and in-process material attributes to monitor and control,” though they note this will vary
depending on the nature of the drug and the manufacturing process used.
The legal experts also stated that the FDA suggests manufacturers identify where and
when the controls and testing for quality attributes and in-process material attributes
should take place. The agency recommends that the identity, strength, quality, and purity
of in-process materials should be tested at the beginning of the production process, at
the completion of “signicant phases,” and after long periods of storage. Companies are
encouraged to use a scientic rationale to determine the proper intervals.
The guidance further addresses what types of equipment and process adjustments
do not typically need additional quality unit approval and how to conduct process
sampling and testing. It also oers specic recommendations for the use of advanced
manufacturing and process models.
The comment period for the draft closed on April 7, 2025. While the FDA aims to oer
exibility for manufacturers in the latest guidance, companies should expect close
scrutiny on compliance with cGMP.
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 63
By the numbers
There were 87 FDA pharmaceutical recalls in Q1
2025, an increase of 7.4% compared to Q4 2024.
The increase in the number of units impacted
was even higher, rising 42.3% from 19.49 million
last quarter to 27.74 million this quarter. Q1
marked a third-consecutive quarter of growth for
recalled units, and the highest gure in the past
2 years.
The leading cause of pharmaceutical recalls in
Q1 2025 was failed specications with 27 events.
That was followed by cGMP deviations with 12
events. Sterility and foreign materials were third
and linked to nine recalls each.
Contamination impacted the most units by
volume with 15.23 million, primarily linked to a
recall of testosterone gel due to the presence
of benzene. There were three other smaller
recalls for acne treatments that contained high
levels of benzene. Subpotency was second by
volume, aecting 8.31 million units with most of
them tied to a recall of alcohol prep pads. Failed
specications impacted 2.53 million units, the
third-highest total of any pharmaceutical risk.
The number of Class I recalls increased quarter-
over-quarter from six in Q4 2024 to 14 in Q1
2025, marking the highest gure for the past year.
The number of units for Class I recalls also grew,
rising from 113,097 to 978,475. The number of
Class II recalls decreased slightly to 64 from 66,
but the number of units recalled rose signicantly
to 26.72 million, up from 19.13 million last
quarter. The number of Class III recalls held
steady at nine, though the number of units
recalled dropped from 247,305 to 44,522.
PHARMACEUTICAL
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Number of recall events by quarter
Number of recalled units by category (top 5)
Number of recall events by category (top 5)
0
Q2 2024
Q1 2024
Q4 2024
Q3 2024
Q1 2025
125
100
75
50
25
0
cGMP
deviations
Failed
specication
Foreign
material
Sterility
Mislabeling
25
20
15
10
5
0
Subpotency
Contamination
Packaging
error
Failed
specication
cGMP
deviations
15M
12M
9M
6M
3M
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 65
FDA has regulations in place to protect the integrity of the
U.S. pharmaceutical supply chain and ensure that safe,
eective, and high-quality drugs reach U.S. consumers.
FDA’s regulatory authority under the Federal Food, Drug, and
Cosmetic Act, as amended by the Drug Supply Chain Security
Act, creates a “closed” drug distribution system, designed to
protect the security and safety of the U.S. drug supply.
Ensuring the integrity of the U.S. pharmaceutical supply
chain requires vigilant attention to issues that may impact
drug availability, safety, ecacy, and quality. These factors
include manufacturing challenges, dynamically changing
demand, and reliance on limited or foreign suppliers for raw
materials, active pharmaceutical ingredients (APIs), and
packaging components. Other concerns for the industry
are disruptions arising from evolving geopolitical dynamics,
natural disasters, and public health crises, as well as
constant uctuations in economic and market factors,
including taris and trade wars.
In recent decades, pharmaceutical manufacturing has
gradually shifted away from domestic production in the U.S.
to foreign-based facilities. This move adds more layers
of challenges and risks. Currently a large portion of the
supply of APIs and raw materials predominantly come from
manufacturing activities in only a handful of countries, such as
China and India, due to lower labor costs, economies of scale,
and other competitive advantages found in those locations.
The pharmaceutical manufacturing industry is at a critical stage in 2025. Drug
supply chain issues, rapid technological advancements, rising regulatory and
compliance complexities, shifting market demands, and geopolitical risks are
converging at lightning speed. Despite their industry-wide prevalence, this
article explores the issues that particularly impact manufacturers of traditional,
small molecule drugs that have historically accounted for the majority of all new
drugs approved by the U.S. Food and Drug Administration (FDA) to date.
Challenges for the
U.S. pharmaceutical
manufacturing industry
JESSICA TIERNEY, PARTNER, JONES DAY
Given that the quality of pharmaceutical drugs heavily
depends on the purity and consistency of the APIs and
other raw materials, maintaining uniform and consistent
quality is a critical issue because even small variations
can potentially compromise the nal nished product’s
safety and ecacy. For U.S.-based companies, maintaining
practical and eective oversight of their foreign-based
suppliers that may be thousands of miles away can be
particularly challenging.
Further, reliance on a limited number of key suppliers—
whether foreign or domestic—can be risky. A single
disruption, such as production delays, quality issues,
nancial instability, or regulatory non-compliance, can cause
serious ripple eects throughout the entire supply chain.
There have also been recent upticks in counterfeiting,
diversion, theft, and imports of falsied, unapproved, or
otherwise ineective or unsafe drugs in the U.S. This
marked increase in the last few years is the result of
many of the same issues and risks previously mentioned.
However, there are some additional factors contributing to
the increase such as high out-of-pocket costs coupled with
higher overall prescription medication used by the U.S.
population, unresolved drug shortages, and the notable
shift of consumers purchasing medications online.
Shifts in the sourcing and availability of pharmaceuticals
allow for greater access to products. However, they also
present a number of challenges. While the vast majority of
online pharmacies operate lawfully within the United States,
there are some bad actors. For example, FDA has warned
consumers and healthcare professionals that some online
websites may use fake “storefronts” to imitate licensed
pharmacies. These sites sell unapproved, counterfeit,
or unsafe drugs in violation of the state and federal laws
that are intended to ensure minimum standards of safety,
ecacy, and quality.
The Centers for Disease Control and Prevention (CDC)
recently warned about potential risks from these illegal
sellers. In addition, the Department of Justice criminally
charged eighteen defendants for running illegal online
pharmacies that shipped millions of unregulated counterfeit
pills containing fentanyl to thousands of U.S. consumers,
allegedly causing numerous injuries and deaths.
Currently, the most frequent cause of FDA pharmaceutical
recalls are impurities and contaminants, sterility concerns,
quality control, and labeling/packaging issues. While recalls
are the most eective way to protect the public from a
defective or potentially harmful drug product, they can have
a big nancial impact on companies because of required
compensation paid to third parties, direct sale losses,
and indirect losses from reputational damage and public
perception. Therefore, to mitigate risk before a voluntary
or mandatory recall is necessary, companies should
prioritize proactive prevention strategies by, for example,
implementing a robust quality management system and
maintaining sucient oversight of suppliers, contract
manufacturers, and other parties involved in the supply
chain to ensure product quality in compliance with FDA
requirements, including the current good manufacturing
practice requirements, and audit these systems on a
regular basis.
Due to FDA’s actions over the years to advance supply
chain resilience and prevent unsafe drugs from reaching
and harming consumers, pharmaceutical recalls have
generally been trending downward. But recent mass layos
at FDA, CDC, and other U.S. health and safety agencies
call into question the government’s ability to continue to
take helpful steps to address potentially adulterated and
misbranded products in the U.S. market.
Furthermore, rumored restructuring within FDA to bring
about a more “centric” regulatory scheme focused not on
product-specic oces but instead on function could shift
the current direction and policies of the agency. Under such
an approach, FDA would potentially reorganize to create
ve new oces. These organizations would focus on 1)
reviews of all products across industries, 2) compliance
and enforcement, 3) administrative services, 4) strategic
planning and innovation, and 5) digital health.
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 67
The proposed digital health oce shows the new administration’s
interest in fostering technologies using computing platforms,
connectivity, and software to drive a revolution in public health. The
pharmaceutical industry is also adopting innovative technologies to
streamline and bolster their manufacturing, supply chain, quality, data
security, and regulatory and compliance capabilities. For instance,
drug manufacturers are incorporating AI into drug applications and
submissions—including clinical and non-clinical phases—as well
as using it as a tool to quickly address and mitigate issues in the
manufacturing and postmarket phases.
FDA has recognized the increased use of AI across a range of
therapeutic areas and throughout the total product life cycle. We caution
that advances in technology—while at rst seemingly a solution to spot
issues and mitigate product concerns—may also contribute to a rise in
errors in quality because product issues are easier to detect.
Pharmaceutical companies should be prepared to deal with potential
challenges and risks. Some of the actions they should take include
conducting thorough risk assessments, implementing robust quality
control measures, and ensuring quality agreements are up-to-date and
that supply contracts contain appropriate risk allocation provisions.
Other recommendations include diversifying supply chains, proactively
addressing regulatory changes, and focusing on cybersecurity and
patient-centric approaches. If only there were a drug for that.
JESSICA TIERNEY, PARTNER, JONES DAY
CONTINUED FROM PREVIOUS PAGE
The views and opinions set forth herein are the personal views or
opinions of the author. They do not necessarily reflect the views or
opinions of the law firm with which she is associated or of Sedgwick.
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 69
Automotive:
There were 87 U.S. automotive recalls in April 2025,
up 20.8% compared to the Q1 2025 monthly average
of 72 events. The number of units recalled by NHTSA
also rose from a monthly average of 1.24 million units
in Q1 2025 to 1.59 million units in April.
Electrical system led to 22 recalls, making it the
leading cause of events for the automotive sector in
April. That was followed by equipment with 13 recalls
and back over prevention systems with nine events.
Engines and engine cooling systems had the most
units recalled in April with 597,965. Back over
prevention systems were second in terms of volume
with 379,751 units aected. The category with the
third-highest number of units impacted was child
seats with one recall that involved 179,845 units.
Consumer products:
There were 34 U.S. consumer product recalls in April
2025, on par with the Q1 2025 monthly average of 34
events. The number of units recalled was lower with
1.41 million units recalled by CPSC in April compared
to the Q1 2025 monthly average of 1.55 million units.
Electronics was the top consumer product recall
category for April 2025 with seven events. Sports &
Recreation, Home Furnishings & Décor, and Toys tied
for second with six recalls each, followed by Children’s
Products with ve events.
Electronics also had the most units recalled in April
with a total of 493,825. Toys was second in terms of
volume with 310,910 units recalled. Home Furnishings
& Décor was third with 307,490 units impacted.
The combination of burns and re was the top risk by
event and volume in Q1 2025. There were ve recalls
linked to this hazard that involved 505,550 units.
Food and drink - FDA:
The FDA issued 49 food and drink recalls in April
2025, up 16.7% from the Q1 2025 monthly average
of 42 events. The number of units recalled in April
decreased by 94.4% to 1.31 million units compared to
the Q1 monthly average of 23.42 million.
Undeclared allergens was the leading cause of FDA
food recalls with 24 events in April 2025, including
four for undeclared color additives. Foreign materials
were the second-leading cause with 10 events.
Unauthorized substances, bacterial contamination,
and excessive substance levels tied for third with
three recalls each. The excessive substance levels
recalls included two for lead.
Foreign materials impacted the largest volume of
FDA food recalled, accounting for 882,230 units in
April 2025. Undeclared allergens was the second-
highest concern by volume, linked to 302,124 units.
Non-bacterial contamination was third with 43,404
units impacted from a single recall for apple juice that
contained the mycotoxin patulin.
Food and drink - USDA:
In April 2025, the USDA issued four recalls, an increase
from the Q1 2025 monthly average of three events.
The number of pounds recalled was also higher rising
319.9% from a monthly average of 141,772 pounds in
Q1 2025 to 595,359 pounds in April.
There were three recalls for pork and one for poultry
in April. In total, 18,792 pounds of poultry and 576,567
pounds of pork were impacted. Two recalls were for a
combination of misbranding and undeclared allergens
which impacted 553,895 pounds. One recall was for
foreign materials which impacted 22,672 pounds.
The fourth event was for excessive levels of nitrate
involving 18,792 pounds of poultry.
Pharmaceutical:
There were 38 pharmaceutical recalls in April 2025.
This is up 31.0% from the Q1 2025 monthly average
of 29 events. In contrast, the number of units recalled
decreased by 88.9% to 1.02 million compared to the
Q1 2025 monthly average of 9.25 million units.
In April 2025, the most common hazard by event
was cGMP deviations with 17 recalls. Sterility was
second with seven events. This was followed by
contamination with three recalls.
Sterility was the leading recall risk by volume,
impacting 604,632 units. cGMP deviations had the
second-highest volume with 267,704 units aected.
Contamination was third with 53,223 units recalled.
The FDA classied one pharmaceutical recall in April
2025 as Class I and two as Class III. The remaining
35 recalls were designated as Class II and impacted
1.00 million units.
Medical device:
In April 2025, there were 79 medical device recalls,
which is in line with the Q1 2025 monthly average of
79 events. However, the number of units recalled rose
by 51.6% from a Q1 monthly average of 6.19 million
units to 9.39 million units in April.
In terms of events, software and safety were the
most cited causes for medical device recalls in April
2025, with 11 events each. Device failure and false
results were second with nine recalls each. Both
manufacturing defects and mislabeling had seven
events in April, making them tied for the third most
common causes for recalls.
False results were the leading cause of recalls by
volume and impacted 5.18 million units, including
two recalls of more than 2.2 million units each for
inaccurate COVID-19 tests.
Sterility concerns led to the second-highest number
of medical device units recalled with 2.40 million. This
was followed by packaging defects with 615,675 units
tied to a single recall for blood pressure kits.
April insights
With Q2 underway, April’s recall data offers an early look at how the year is
unfolding across key industries. While Q1 set the pace, April reveals shifts in
recall drivers, regulatory focus, and product categories to watch.
Explore the insights below for a clearer view of how the landscape is evolving,
and what to keep an eye on as we head toward the mid-year mark:
RECALL INDEX 2024 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 71
Businesses across all sectors need to consider whether it
is possible or benecial to move operations and sourcing
to the U.S. to avoid taris, though often the necessary
components are not available domestically. The world
is also watching to see if new trade alliances will form
that exclude the U.S. from historically friendly trading
relationships. Already, there are discussions about
countries turning to China, which had been shunned in
favor of the U.S. in recent years.
Given the uncertainty, companies must plan for risks
across a variety of areas, including:
• Business interruptions
• Supply chain challenges
• Regulatory and legislative changes
• Financial impacts
• Product updates, upgrades, and warranty work
• Product recalls and market withdrawals
• Data privacy and cybersecurity issues
• Innovation and advancements in technology
• Dynamic consumer demand
• Customer and partner apprehension
Unfortunately, product recalls and other incidents are
inevitable in today’s business environment. Many
regulatory agencies recommend, even mandate, that
companies have recall, incident response, and/or risk
management plans in place as part of their standard
business processes. Advance planning means better
protection for your customers, brand, and bottom line when
product issues do occur.
As regulatory pressures intensify, it’s crucial for
manufacturers and supply chain partners to assess
how prepared they are to withstand a product incident
or crisis. Sedgwick product recall is proud oer its
interactive Recall Readiness Audit.
Simply answer 15 quick questions and you’ll receive
a personalized ‘recall readiness score’ and a detailed
report featuring tailored recommendations based on
your responses. Protect your brand and bottom line
today, visit: www.recall-ready.app.
Whether planning for or actively managing a product safety
crisis, leveraging the experience and insights of an external
partner can save millions of dollars in regulatory and
litigation costs, as well as time and stress on other internal
resources. In addition, their expertise will help you honor
your commitments to customers, supply chain partners,
industry groups, and regulators, while protecting your
reputation among the stakeholders that matter most.
The new administration’s actions and related measures by a very divided
Congress presented challenges for businesses in the first quarter of 2025 in
terms of planning and supply chain security. Discussions around tariffs will
certainly continue in the second quarter, if not longer.
Conclusion
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 73
When their reputations are on the line, leading global
brands trust Sedgwick Recall. With more than 30 years of
experience managing complex product recalls and crisis
events across industries and borders, we provide the
strategic expertise and operational precision needed to
protect consumers and safeguard businesses.
Sedgwick has helped companies in 150+ countries prepare and adapt during some of
the most challenging events in their history. Our three decades of global experience
executing 7,000+ recalls aecting 500+ million units gives us unparalleled insights that
we put to work to help you.
We are the leader in global product recall services. We’ve managed some of the largest
product recalls and are a recognized authority in recall and incident response solutions.
We oer a full suite of end-to-end solutions to help businesses navigate complex and
evolving regulatory landscapes with condence. Whether you need help managing
the entire process from pre-incident planning to nal disposal of a defective product
or modular support for any step in between, we work as an extension of your team to
resolve issues quickly and in compliance with all regulatory requirements while helping
you use your resources wisely.
We also leverage our extensive skills in acting quickly in a crisis to provide expert
incident response solutions. Our experienced team helps businesses operate well under
pressure to nd the best solution for dynamic, evolving situations. We will partner with
you throughout the event to assess rapidly changing situations and continually adjust our
plans to achieve the best outcome for your business, including rapid notications, scaling
up a multilingual call center, or removing a product from the market.
Sedgwick oers the experience and the global reach to help you with proactive planning
to mitigate risk nd quick, eective actions in times of crisis.
To nd out more about our product recall capabilities, contact us today.
Sedgwick Recall
Website: sedgwick.com/product-recall
Email: brand.protection@sedgwick.com
RECALL INDEX 2025 EDITION 1 | Product Recall Data, Trends and Predictions for US Industries 75
