Browse Drug Recalls
54 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 54 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 54 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 22, 2019 | Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, M... | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed du... | Class II | Ascend Laboratories LLC |
| Nov 14, 2018 | Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by:... | Presence of Foreign Substance; metal shard found in tablet | Class II | Ascend Laboratories LLC |
| May 5, 2017 | AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactu... | PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled w... | Class III | Ascend Laboratories LLC |
| Nov 2, 2016 | Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactu... | Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of... | Class II | Ascend Laboratories LLC |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.