FDA Drug Recall Statistics

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 1,279 recalls per year since 2012. The continued frequency of FDA recalls has sparked both skepticism and scrutiny from the public. This 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.

FDA Drug Recall Resources and Frequently Asked Questions

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.

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 (Jan-June) 47 348 48 443
Total 1,317 10,168 1,302 12,787

Since 2012:

  • There have been 12,787 total drug recalls issued by the FDA
  • On average, 1,279 drugs are recalled every year
  • 1,317 Class I drug recalls have been issued by the FDA
  • 10,168 Class II drug recalls have been issued by the FDA
  • 1,302 Class III drug recalls have been issued by the FDA
  • Class I makes up 10.3% of all drug recalls
  • Class II makes up 79.5% of all drug recalls
  • Class III makes up 10.3% 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 2021, the FDA drug recall statuses are: Ongoing Recalls: 3,327 Completed Recalls: 350 Terminated Recalls: 9,110

Status of FDA Drug Recalls Per Year

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

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 Top 100 Most Recalled Pharmaceutical Firms

This data shows how many drug recalls have been issued per firm since 2012.

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 282
Cardinal Health Inc. 199
Franck’s Lab Inc., d.b.a. Franck’s Compounding Lab 198
Teva Pharmaceuticals USA 158
ICU Medical Inc 146
Altaire Pharmaceuticals, Inc. 135
KRS Global Biotechnology, Inc 129
Assurance Infusion 118
Martin Avenue Pharmacy, Inc. 118
Herbal Doctor Remedies 113
Lowlite Investments, Inc. D/B/A Olympia Pharmacy 105
JD & SN Inc., dba Moses Lake Professional Pharmacy 101
SCA Pharmaceuticals 101
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 100
Pharm D Solutions, LLC 100
Advanced Pharma Inc. 99
Dr. Reddy’s Laboratories, Inc. 98
Wells Pharmacy Network LLC 97
Medaus, Inc. 96
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
Pfizer Inc. 75
Medline Industries Inc 74
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
Health Innovations Pharmacy, Inc 65
US Compounding Inc 65
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical 64
Akorn, Inc. 62
Oregon Compounding Centers, Inc. dba Creative Compounds 56
The Medicine Shoppe Pharmacy 55
Lincare, Inc. 54
Product Quest Manufacturing LLC 54
American Health Packaging 52
Baxter Healthcare Corp. 52
Cantrell Drug Company 52
Promise Pharmacy, LLC 51
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
Natures Pharmacy & Compounding Center 48
Novartis Consumer Health 48
the Compounder 47
Wockhardt Usa Inc. 45
TG United, Inc. 44
Abbott’s Compounding Pharmacy, Inc. 43
Nora Apothecary and Alternative Therapies, Inc. 43
Torrent Pharma Inc 43
Apotex Inc. 41
Zydus Pharmaceuticals USA Inc 41
Fresenius Kabi USA, LLC 40
Sun Pharmaceutical Industries, Inc. 40
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 39
Baptist Health Medical Towers Pharmacy and Infusion Services 38
Central Admixture Pharmacy Services, Inc. 38
Lloyd Inc. of Iowa 36
NingBo Huize Commodity Co.,Ltd. 36
Torrent Pharma Inc. 36
Aurobindo Pharma USA Inc. 34
Colonia Care Pharmacy 34
Sentara Enterprises 34
Taro Pharmaceuticals U.S.A., Inc. 33
Teva Pharmaceuticals USA, Inc. 33
AuroMedics Pharma LLC 32
CMC Enterprise Pharmacy 32
Hartley Medical Center Pharmacy, Incorporated 32
QuVa Pharma, Inc. 32
AVKARE Inc. 31
Coast Quality Pharmacy, LLC dba Anazao Health 31
The Apothecary Shoppe LLC 31
Franck’s Lab Inc dba Trinity Care Solutions 30
Golden State Medical Supply Inc. 30
VistaPharm, Inc. 30
Baxter Healthcare Corporation 28
MasterPharm LLC 28
Pharmakon Pharmaceuticals 28
West-Ward Pharmaceutical Corp. 28
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 34th 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 12028
Canada 554
India 61
China 52
Mexico 37
Germany 15
Spain 12
Guyana 7
Turkey 6
Guatemala 5
United Arab Emirates 5
Israel 2
Switzerland 1
United Kingdom 1
  • The FDA has issued 12,028 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
Florida 1254
New Jersey 1207
Illinois 1088
Tennessee 881
California 828
Washington 769
New York 723
North Carolina 708
Texas 695
Ohio 458
Pennsylvania 403
Michigan 342
Arizona 323
Arkansas 285
Nevada 222
Indiana 191
Alabama 139
Maryland 127
Mississippi 125
Oklahoma 123
Oregon 122
Massachusetts 120
Georgia 109
Connecticut 104
West Virginia 88
Iowa 75
Missouri 59
Nebraska 59
Virginia 51
Minnesota 48
Utah 47
South Carolina 42
Colorado 35
Kansas 31
New Mexico 24
Kentucky 22
New Hampshire 16
Wisconsin 16
Idaho 12
Montana 12
Delaware 8
Vermont 6
Louisiana 5
Maine 1
Rhode Island 1
South Dakota 1
Wyoming 1
  • Florida is the U.S. state with the leading number of firms experiencing recalls, with 1,254 FDA recalls issued since 2012.
  • The 3 states with highest number of firms experiencing drug recalls are Florida (1,254), New Jersey (1,207), and Illinois (1,088).

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, 2021.

  • There have been 15,605,990 total adverse event reports.
  • There have been 8,632,040 expedited adverse event reports.
  • There have been 6,439,586 non-expedited adverse event reports.
  • There have been 534,364 direct adverse event reports.
  • There have been 8,147,902 serious reports (excluding death).
  • There have been 1,433,954 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.


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