Drug Safety Recalls
Search 17,528 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 |
|---|---|---|---|---|
| Mar 9, 2026 | Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactu... | Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidiz... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Mar 3, 2026 | Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ... | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-... | Class II | Rising Pharma Holding, Inc. |
| Feb 26, 2026 | Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Vall... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 24, 2026 | Isotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs... | Failed Dissolution Specifications | Class II | MYLAN PHARMACEUTICALS INC |
| Feb 18, 2026 | Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufac... | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... | Class III | Cipla USA, Inc. |
| Feb 18, 2026 | MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal S... | Stability Data Does Not Support Expiry Date. | Class II | HTO Nevada Inc. dba Kirkman |
| Feb 18, 2026 | MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1... | Stability Data Does Not Support Expiry Date. | Class II | HTO Nevada Inc. dba Kirkman |
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. | 274 |
| 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 | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | 140 |
| 15 | Glenmark Pharmaceuticals Inc., USA | 139 |
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 17,528 drug safety records from 2006 to 2026.