Drug Safety Recalls

Search 17,830 FDA drug recalls and enforcement actions. Check if medications you use have been recalled for safety reasons.

0 Total Recalls
0 Class I Recalls
0 Class II Recalls
0 Years of Data

Search Recalls

Find FDA drug recalls by medication name, reason, or manufacturer. Covers all enforcement actions since 2006.

Browse by Year

View drug recalls by year to see trends in pharmaceutical safety enforcement.

Latest Drug Recalls

Most recently initiated FDA drug safety recalls and enforcement actions.

DateProductReasonClassFirm
Jul 9, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the pa... Class II CareFusion 213, LLC
Jul 6, 2026 CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Sing... Lack of Assurance of Sterility Class II Chiesi USA, Inc.
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 26, 2026 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER ... Class II Lannett Company Inc.
Jun 25, 2026 Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-0... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - ... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Was... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BU... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc

Recalls by Year

FDA drug recalls initiated per year.

YearRecalls
2026389
2025778
2024557
20231,122
20221,392
YearRecalls
20211,152
2020930
20191,788
20181,681
20171,141
YearRecalls
20161,198
20151,733
20141,309
20132,085
2012534
YearRecalls
201134
20104
20072
20061

Top Recalling Firms

Companies with the most FDA drug recall actions.

#FirmRecalls
1Aidapak Services, LLC538
2Attix Pharmaceuticals470
3King Bio Inc.465
4The Compounding Pharmacy of America383
5Main Street Family Pharmacy, LLC299
6Pharmedium Services, LLC282
7Central Admixture Pharmacy Services, Inc.275
8Cardinal Health Inc.213
9Franck's Lab Inc., d.b.a. Franck's Compounding Lab198
10Teva Pharmaceuticals USA196
11Akorn, Inc.176
12Dr. Reddy's Laboratories, Inc.163
13Mckesson Medical-Surgical Inc. Corporate Office157
14First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy140
15Glenmark Pharmaceuticals Inc., USA140

How It Works

1

Search Drug Recalls

Enter a medication name, active ingredient, or manufacturer. Our database covers every FDA drug enforcement action from 2006 to 2026.

2

Review the Details

See the full recall information including classification level, reason for recall, recalling firm, and whether the medication poses serious health risks.

3

Take Action

If you have a recalled medication, contact your healthcare provider for alternatives. Check the recall details for instructions on returning or disposing of the medication.

Frequently Asked Questions

An FDA drug recall is an action taken to remove a medication from the market because it may be defective, contaminated, improperly manufactured, or mislabeled. Recalls can be initiated voluntarily by the manufacturer or requested by the FDA. Common reasons include cGMP violations, impurity contamination (such as NDMA or other nitrosamines), potency issues, failed sterility testing, and labeling errors.

The FDA classifies drug recalls into three levels. Class I is the most serious, the product may cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible adverse health effects. Class III is the least serious, the product is unlikely to cause adverse health effects.

Do not stop taking critical medications abruptly without consulting your doctor. Contact your healthcare provider for guidance on alternatives. Return recalled medication to the pharmacy for a refund. Report adverse reactions to the FDA through their MedWatch program.

All drug recall data comes from the U.S. FDA through the openFDA enforcement database. We maintain 17,830 drug safety records from 2006 to 2026.