Browse Drug Recalls
412 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 412 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 412 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 4, 2012 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on... | Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut... | Class II | Amedra Pharmaceuticals LLC |
| Dec 4, 2012 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on... | Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut... | Class II | Amedra Pharmaceuticals LLC |
| Dec 4, 2012 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on... | Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut... | Class II | Amedra Pharmaceuticals LLC |
| Nov 20, 2012 | Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules... | Failed Dissolution Test Requirements | Class II | Upsher Smith Laboratories, Inc. |
| Oct 10, 2012 | QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packa... | Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months ... | Class II | American Health Packaging |
| Oct 3, 2012 | Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., M... | Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (ex... | Class II | Paddock Laboratories, LLC |
| Sep 27, 2012 | Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd B... | Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 mon... | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 23, 2012 | Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters pe... | Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratori... | Class II | American Health Packaging |
| Jun 29, 2012 | Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottl... | Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dis... | Class II | Prometheus Laboratories Inc. |
| Mar 29, 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets... | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... | Class III | McKesson Packaging Services |
| Mar 29, 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets... | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... | Class III | McKesson Packaging Services |
| Mar 8, 2012 | Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manuf... | Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month tim... | Class II | Shionogi Inc. |
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.