FDA Drug Recall Statistics [2024]

The U.S. Food and Drug Administration (FDA) has the job of preserving the public health of all U.S. consumers through the regulation of a myriad of potential health risks; this includes human and veterinary drugs, biological products, medical devices, food, cosmetics, and products that emit radiation.

While the FDA’s mission is to protect consumers, many previously-approved items have resulted in recalls, long-term injuries, and lawsuits, calling into question the efficacy of their approval process.

Drugs alone have averaged 1,284 recalls per year since 2012. The continued frequency of FDA recalls has sparked both skepticism and scrutiny from the public. This comprehensive study will take a more granular look at FDA recall process since 2012 up until now.

We cover which firms experience the most recalls, how the FDA’s adverse events reporting system relates to drug recalls, and how you as a consumer can report injuries from the medical treatment you’ve been given.

Summary of Findings

• There has been a total of 15,749 drug recalls since 2012, with 15,351 recalls specifically happening in the U.S.
• Since 2012, there have been 2,193 ongoing recalls, 807 completed recalls, and 13,254 terminated recalls.
• Aidapak Services, LLC, Attix Pharmaceuticals, and King Bio Inc. are the most recalled pharmaceutical firms in the United States.
• The three states with the highest number of firms experiencing drug recalls are New Jersey (1,735), Florida (1,438), Illinois (1,266).
• There have been 22,261,316 total adverse event reports, and the frequency of adverse event reports have increased every year since 2012.

FDA Drug Recall Resources and Frequently Asked Questions

• What Is the FDA Drug Recall Process?
• FDA Drug Recall Status: Terminated, Completed, Ongoing
• The Top 100 Most Recalled Pharmaceutical Firms
• Which Country’s Pharmaceutical Firms Experience the Most Drug Recalls?
• Which U.S. State Has Firms Experiencing the Most Drug Recalls?
• What is FAERS?
• Adverse Event Statistics
• Do Drug Recalls Have to Be Issued After An Adverse Event Is Reported?
• How to Report a Drug Injury to the FDA

What Is the FDA Drug Recall Process?

According to the FDA, a drug recall is the most effective way to protect the public from a defective or potentially harmful drug. A recall is defined as a firm’s removal or correction of a distributed product that the FDA deems is in violation of its laws, but does not necessarily include a market withdrawal or stock recovery. This is because the FDA recalls drugs most commonly on a voluntary basis, and leaves it up to the responsibility of drug manufacturers and distributors to protect the public from high-risk products. Responsible firms are advised by the FDA on how to conduct an effective recall themselves.

How Are Drugs Eligible For Recall Discovered?

Most FDA drug recalls are initiated in one of the following three ways:

1. A recall happens voluntarily by the product’s manufacturer or distributor.
2. A company discovers that its product is defective and recalls it.
3. The FDA will notify a company selling a defective drug and either suggest or (in rare, but urgent cases) request a recall.

How Does the FDA Assess the Severity of a Drug’s Risk?

In order to classify a drug recall accordingly, the FDA follows a health hazard evaluation that considers the following factors:

• Any existing diseases/injuries the product has inflicted.
• Whether any existing conditions could contribute to a larger health hazard in the future.
• An assessment of the implications the potential hazard has if it were to exist, with special attention given to the individuals who are at the greatest risk of consequences should they be exposed to the hazard.
• Assessment of the degree of seriousness the health hazard would impose on most at-risk groups.
• Assessment of the likelihood that the risk occurs.
• Assessment of the hazard’s short and long-term consequences should it occur.

Once a health hazard evaluation is conducted, the FDA categorizes the drug’s risk by class. These are referred to as Class I, Class II, and Class III, and all depend on the severity of the discovered risk:

Class	Definition
Class I	A dangerous or defective product that could cause severe health complications, or even death.
Class II	A product with the potential to cause a temporary or serious health problem.
Class III	A product that is unlikely to result in any health reaction, but that violates an FDA labeling or manufacturing law.

The table below details the amount of recalls per year by class and total recalls per year. [Updated for 2024]

Year	Class I	Class II	Class III	Total
2012	23	370	66	459
2013	67	1,135	163	1,365
2014	152	1,252	148	1,552
2015	105	1,812	135	2052
2016	130	934	167	1,231
2017	66	833	179	1,078
2018	104	1,155	146	1,405
2019	513	1,500	150	2,163
2020	110	829	100	1,039
2021	138	348	48	534
2022	83	1,142	93	1,318
2023	67	1,065	88	1,220
2024 (Jan-June)	78	220	35	333
Total	1,636	12,595	1,518	15,749

Since 2012:

• There have been 15,749 total drug recalls issued by the FDA
• On average, 1,284 drugs are recalled every year, based upon the data from 2012 to 2023.
• 1,636 Class I drug recalls have been issued by the FDA
• 12,595 Class II drug recalls have been issued by the FDA
• 1,518 Class III drug recalls have been issued by the FDA
• Class I makes up 10.4% of all drug recalls
• Class II makes up 80% of all drug recalls
• Class III makes up 9.6% of all drug recalls

FDA Drug Recall Status: Terminated, Completed, Ongoing

While all news of FDA recalls are reported, some drugs are in different stages of determination, labelled either ongoing, completed, or terminated.

Ongoing Recalls: A recall that is in the process of taking the necessary safety precautions advised by the FDA.

Completed Recalls: A recall that reaches the point at which the firm has retrieved and captured all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections advised by the FDA.

Terminated Recalls: A recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product to the best of their ability.

What Is the Status of All FDA Recalled Drugs?

Between 2012 and June 2024, the FDA drug recall statuses are:

Ongoing Recalls: 2,193

Completed Recalls: 807

Terminated Recalls: 13,254

Status of FDA Drug Recalls Per Year

The table below highlights the status of FDA drug recalls per year. The data is updated as of June 2024.

Classification Year	Status	Count of Status
2012	Ongoing	1
2012	Terminated	458
2013	Completed	29
2013	Ongoing	118
2013	Terminated	1218
2014	Ongoing	36
2014	Terminated	1516
2015	Completed	1
2015	Ongoing	8
2015	Terminated	2043
2016	Ongoing	57
2016	Terminated	1174
2017	Completed	100
2017	Ongoing	126
2017	Terminated	852
2018	Completed	52
2018	Ongoing	233
2018	Terminated	1120
2019	Completed	132
2019	Ongoing	1430
2019	Terminated	601
2020	Completed	32
2020	Ongoing	885
2020	Terminated	122
2021	Completed	4
2021	Ongoing	433
2021	Terminated	6
2022	Completed	293
2022	Ongoing	310
2022	Terminated	718
2023	Completed	160
2023	Ongoing	724
2023	Terminated	336
2024	Completed	1
2024	Ongoing	331
2024	Terminated	1

This information serves as an indication of how long the process can take for an FDA drug recall to be officially terminated, demonstrated by 2012 and 2013 drug recalls remaining in the ongoing/completed phase.

The Most Recalled Pharmaceutical Firms

This data shows how many drug recalls have been issued per firm since 2012. The data below is updated as of June 2024.

Recalling Firm Name	Amount of Recalls
Aidapak Services, LLC	538
Attix Pharmaceuticals	470
King Bio Inc.	465
The Compounding Pharmacy of America	383
Main Street Family Pharmacy, LLC	299
PharMEDium Services, LLC	289
Central Admixture Pharmacy Services, Inc	273
Cardinal Health Inc.	208
Franck’s Lab Inc., d.b.a. Franck’s Compounding Lab	198
Teva Pharmaceuticals USA	196
Akorn, Inc.	193
Mckesson Medical-Surgical Inc.	150
ICU Medical Inc	148
Dr. Reddy’s Laboratories Inc.	146
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy.	140
Altaire Pharmaceuticals, Inc.	135
Vita Pharmacy, LLC.	130
KRS Global Biotechnology, Inc	129
Assurance Infusion	118
Martin Avenue Pharmacy, Inc.	118
Family Dollar Stores, LLC	117
Herbal Doctor Remedies	113
Lupin Pharmaceuticals	107
SCA Pharmaceutical Industries Inc	107
Sun Pharmaceuticals	107
Pfizer Inc.	106
Lowlite Investments, Inc. D/B/A Olympia Pharmacy	105
Perigo Company PLC	104
JD & SN Inc., dba Moses Lake Professional Pharmacy	101
Pharm D Solutions, LLC	100
Advanced Pharma Inc.	99
Wells Pharmacy Network LLC	97
Medaus, Inc.	96
Olympia Compounding Pharmacy dba Olympia Pharmacy	94
Western Drug	91
Pharmakon Pharmaceuticals, Inc.	89
RXQ Compounding LLC	88
Beacon Hill Medical Pharmacy, P.C.	86
Synergy Rx	81
Tri-Coast Pharmacy	80
Key Pharmacy and Compounding Center	79
FVS Holdings, Inc. dba. Green Valley Drugs	78
Infusion Options, Inc.	76
Accord Healthcare, Inc	75
Medline Industries Inc	75
Washington Homeopathic Products, Inc.	75
Nephron Sterile Compounding Center, LLC	72
American Pharmaceutical Ingredients LLC	71
Lupin Pharmaceuticals Inc.	71
Mylan Pharmaceuticals Inc.	70
Reliable Rexall-A Compounding Pharmacy	70
Walgreens Infusion Services	69
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy	68
Kroger Specialty Pharmacy, Inc.	67
Sage Products Inc	66
Ultra Seal Corporation	66
Health Innovations Pharmacy, Inc	65
US Compounding Inc	65
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical	64
Teligent Pharma, Inc	63
Edge Pharma, LLC	62
American Health Packaging	59
Pharmacy Innovations	59
Oregon Compounding Centers, Inc. dba Creative Compounds	56
The Medicine Shoppe Pharmacy	55
Lincare, Inc.	54
Product Quest Manufacturing LLC	54
Aurobindo Pharma USA Inc	53
Sentara Fusion Services	53
Astral SteriTech Private Ltd.	52
Baxter Healthcare Corp.	52
Cantrell Drug Company	52
Promise Pharmacy, LLC	52
RemedyRepack Inc.	52
TMC Acquisition LLC.	52
Specialty Medicine Compounding Pharmacy	51
Well Care Compounding Pharmacy	51
Avella of Deer Valley, Inc. Store 38	50
Clinical Specialties Compounding Pharmacy	50
Partell Specialty Pharmacy	49
Downing Labs, LLC	48
Glenmark Pharmaceuticals Inc., USA	48
Natures Pharmacy & Compounding Center	48
Novartis Consumer Health	48
the Compounder	47
Golden State Medical	45
Wockhardt Usa Inc.	45
Fresenius Kabi USA, LLC	45
TG United, Inc.	44
Torrent Pharma Inc	43
Abbott’s Compounding Pharmacy, Inc.	43
Cardinal Health	43
Nora Apothecary and Alternative Therapies, Inc.	43
Apotex Inc.	41
Preferred Pharmaceuticals	41
Zydus Pharmaceuticals USA Inc	41
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma	39
Baptist Health Medical Towers Pharmacy and Infusion Services	38
Torrent Pharma Inc.	38
Baxter Healthcare Corporation	37
AuroMedics Pharma LLC	36
Lloyd Inc. of Iowa	36
Michigan Herbal Remedies	36
NingBo Huize Commodity Co., Ltd	36
MICHIGAN HERBAL REMEDIES	36
NingBo Huize Commodity Co.,Ltd.	36
SterRx, LLC	35
Taro Pharmaceuticals	35
The Harvard Drug Group	35
Colonia Care Pharmacy	34
Sentara Enterprises	34
ULTRAtab Laboratories, Inc	34
AVKARE Inc.	33
QuVa Pharma, Inc.	33
Teva Pharmaceuticals USA, Inc.	33
AuroMedics Pharma LLC	32
CMC Enterprise Pharmacy	32
Hartley Medical Center Pharmacy, Incorporated	32
Direct Rx	32
QuVa Pharma, Inc.	32
VistaPharm, Inc.	32
Coast Quality Pharmacy, LLC dba Anazao Health	31
The Apothecary Shoppe LLC	31
Franck’s Lab Inc dba Trinity Care Solutions	30
Jubilant Cadista Pharmaceuticals, Inc.	29
Macleods Pharma Usa Inc.	28
MasterPharm LLC	28
Pharmakon Pharmaceuticals	28
West-Ward Pharmaceutical Corp.	28
Carefusion 213, LLC	27
Noven Pharmaceuticals, Inc.	27

• Aidapak Services, LLC has been the most highly recalled firm since 2012.
  • Located in Vancouver, WA
  • 538 recalled drugs
  • Firm has only 10 employees
  • Plastic Resin & Synthetic Fiber Manufacturing Industry
  • Firm averages $1.72 million annually
• The top 3 most FDA recalled firms are Aidapak Services, LLC (538), Attix Pharmaceuticals (470), and King Bio Inc (465).
• Pfizer is the 26th most highly recalled firm by the FDA.

Which Country’s Pharmaceutical Firms Experience the Most Drug Recalls?

Recalling Firm Country	Count of Recalling Firm Country
United States	15,351
Canada	560
India	156
China	63
Mexico	43
Jordan	17
Germany	15
Spain	13
Guyana	7
Turkey	6
Guatemala	5
United Arab Emirates	5
Japan	4
Israel	2
Switzerland	3
Aruba	2
United Kingdom	1
Dominican Republic	1

• The FDA has issued 15,351 drug recalls in the U.S. since 2012
• 94% of FDA drug recalls have been in the United States
• 4% of FDA drug recalls have been in Canada

Which U.S. State Has Firms Experiencing the Most Drug Recalls?

Below is a list of the U.S. states that have experienced recalls since 2012, and how many recalls have been issued in each state:

State	Number of Recalls
New Jersey	1735
Florida	1438
Illinois	1266
New York	982
California	949
Tennessee	931
Texas	905
North Carolina	813
Washington	775
Pennsylvania	622
Ohio	555
Arizona	496
Michigan	447
Virginia	402
Arkansas	292
Nevada	231
Indiana	204
Connecticut	176
Maryland	173
Mississippi	158
West Virginia	152
South Carolina	149
Alabama	141
Massachusetts	141
Georgia	139
Oregon	136
Oklahoma	133
Missouri	107
Iowa	84
Kentucky	80
Minnesota	72
Colorado	70
Vermont	62
Nebraska	59
Kansas	56
Utah	51
New Mexico	31
Delaware	22
New Hampshire	17
Wisconsin	17
Idaho	12
Montana	12
Louisiana	8
Rhode Island	7
South Dakota	4
Maine	1
Wyoming	1
Alaska	0
Hawaii	0
North Dakota	0

• New Jersey is the U.S. state with the leading number of firms experiencing recalls, with 1,735 FDA recalls issued since 2012.
• The 3 states with highest number of firms experiencing drug recalls are New Jersey (1,735), Florida (1,438), and Illinois (1,266).

What is FAERS?

The FDA Adverse Events Reporting System (FAERS) Public Dashboard, is an online database created by the FDA in order to query adverse event reports in an easily accessible way for the general public. All information in the dashboard has been reported to the FDA by pharmaceutical companies, healthcare providers, and consumers themselves.  FAERS reports include both drug and biologic product injuries. The public dashboard categorizes adverse event reports by report type: Direct, Mandatory, Expedited, and Non-Expedited:

Report Type	Definition
Direct	Voluntarily submitted reports to the FDA through the MedWatch program by consumers and healthcare workers.
Mandatory	Reports submitted by manufacturers, and categorized as either expedited or non-expedited.
Expedited	Contains at least one adverse event that is not currently disclosed in the labeling and causes a serious outcome on the user.
Non-Expedited	Do not meet criteria for expedited reports, but include reports that are either serious and expected, non-serious and unexpected, or non-serious and expected.

What Is an Adverse Event?

An adverse event is any event that causes unintended and sometimes harmful occurrences to a patient as a result of the medical treatment they received. An occurrence still qualifies as an adverse event whether it was preventable or nonpreventable, intended or unintentional.  According to the CDC, adverse drug events cause around 1.3 million emergency department visits per year, and about 350,000 of those patients need to be hospitalized for further treatment after the drug event occurs.

What Is an Example of an Adverse Drug Reaction?

Examples of adverse events include any symptoms or diseases associated with a patient’s medical care. Some common examples of adverse drug reactions include:

• Rashes
• Allergic reactions
• Kidney damage
• Anemia
• Nerve injuries
• Overdoses

Adverse Event Statistics

All the below adverse event data includes reports from 2012 until June 2024.

• There have been 22,261,316 total adverse event reports.
• There have been 12,448,889 expedited adverse event reports.
• There have been 9,059,767 non-expedited adverse event reports.
• There have been 752,660 direct adverse event reports.
• There have been 11,779,833 serious reports (excluding death).
• There have been 1,935,894 death reports.
• Frequency of adverse event reports have increased every year since 2012.

Do Drug Recalls Have to Be Issued After An Adverse Event Is Reported?

According to FAERS, not all reports of injuries result in a recall. The mission the FDA’s adverse events reporting system has is to make the FDA aware of the severity of the drug reaction, initiate an assessment of its short and long-term implications, and notify manufacturers, distributors and consumers of its findings. While this sometimes results in a recall, it more commonly results in one of the following actions:

• Updating a product’s labeling information
• Restricting the use of the drug
• Communicating new safety information to the public

How Can I Report a Drug Injury to the FDA?

Anyone is able to report an adverse event using the FDA’s MedWatch Voluntary Reporting Program. Reporting is essential for keeping track of a drug’s behavior and contributes to keeping the FDA, pharmaceutical companies, and general public informed. If you’ve been injured by a drug, a Washington D.C. drug injury lawyer can help you recover.

Citations

• https://datadashboard.fda.gov/ora/cd/recalls.htm
• https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/45beeb74-30ab-46be-8267-5756582633b4/state/analysis
• https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls
• https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard
• https://www.accessdata.fda.gov/scripts/medwatch/index.cfm