Drug Safety Recalls

Search 17,936 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
Aug 24, 2026 Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) ... Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclo... Class II Hikma Pharmaceuticals USA INC.
Aug 13, 2026 Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx o... Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance c... Class II Apotex Corp.
Aug 12, 2026 Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. ... Presence of Particulate matter. Class I B BRAUN MEDICAL INC
Aug 10, 2026 Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx ... Presence of particulate matter:An internal investigation at the firm found the product to contain... Class I Fresenius Kabi USA, LLC
Aug 10, 2026 Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus,... CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for micro... Class II Church & Dwight Co., Inc.
Aug 7, 2026 Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 5140... CGMP deviations: tablets with black specks. Class II Golden State Medical Supply Inc.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-coun... Subpotent Drug Class II ACCORD HEALTHCARE, INC.

Recalls by Year

FDA drug recalls initiated per year.

YearRecalls
2026495
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
14Glenmark Pharmaceuticals Inc., USA141
15First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy140

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 17,936 drug safety records from 2006 to 2026.