Drug Safety Recalls
Search 18,074 FDA drug recalls and enforcement actions. Check if medications you use have been recalled for safety reasons.
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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 13, 2026 | Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose V... | Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene terapha... | Class I | Par Health USA, LLC |
| Oct 13, 2026 | Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose V... | Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene terapha... | Class I | Par Health USA, LLC |
| Oct 9, 2026 | Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-... | Lack of sterility assurance. | Class II | Right Value Drug Stores LLC |
| Oct 7, 2026 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides... | Failed dissolution specifications | Class II | STRIDES PHARMA INC |
| Oct 6, 2026 | Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, ... | Out of specification due to dissolution. | Class II | Ascend Laboratories, LLC |
| Oct 6, 2026 | Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distribute... | Presence of Foreign Tablets/Capsules | Class II | American Health Packaging |
| Oct 6, 2026 | Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx on... | Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity. | Class II | Hikma Pharmaceuticals USA INC. |
| Oct 1, 2026 | Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacter... | Microbial Contamination of Sterile Products | Class I | Greenwich Rx |
| Oct 1, 2026 | Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx On... | Failed Impurities/Degradation Specifications. | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 1, 2026 | Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only... | Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications | Class III | Viatris, Inc. |
Recalls by Year
FDA drug recalls initiated per year.
Top Recalling Firms
Companies with the most FDA drug recall actions.
| # | Firm | Recalls |
|---|---|---|
| 1 | Aidapak Services, LLC | 538 |
| 2 | Attix Pharmaceuticals | 470 |
| 3 | King Bio Inc. | 465 |
| 4 | The Compounding Pharmacy of America | 383 |
| 5 | Main Street Family Pharmacy, LLC | 299 |
| 6 | Pharmedium Services, LLC | 282 |
| 7 | Central Admixture Pharmacy Services, Inc. | 275 |
| 8 | Cardinal Health Inc. | 213 |
| 9 | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | 198 |
| 10 | Teva Pharmaceuticals USA | 196 |
| 11 | Akorn, Inc. | 176 |
| 12 | Dr. Reddy's Laboratories, Inc. | 163 |
| 13 | Mckesson Medical-Surgical Inc. Corporate Office | 157 |
| 14 | Glenmark Pharmaceuticals Inc., USA | 141 |
| 15 | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | 140 |
How It Works
Search Drug Recalls
Enter a medication name, active ingredient, or manufacturer. Our database covers every FDA drug enforcement action from 2006 to 2026.
Review the Details
See the full recall information including classification level, reason for recall, recalling firm, and whether the medication poses serious health risks.
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 18,074 drug safety records from 2006 to 2026.