Browse Drug Recalls
10 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 10 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 10 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Apr 10, 2018 | Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 | Presence of Foreign Tablets/Capsules | Class III | Aidarex Pharmaceuticals LLC |
| Sep 5, 2017 | ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhard... | Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lo... | Class III | Aidarex Pharmaceuticals LLC |
| Sep 5, 2017 | Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aid... | Failed Impurities/Degradation Specification; out-of-specification results for individual unknown ... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 1, 2016 | CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. ... | Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity. | Class II | Aidarex Pharmaceuticals LLC |
| Jun 1, 2016 | Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, ... | Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity. | Class III | Aidarex Pharmaceuticals LLC |
| Jun 1, 2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA,... | CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufactu... | Class III | Aidarex Pharmaceuticals LLC |
| May 22, 2014 | Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex P... | Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofl... | Class II | Aidarex Pharmaceuticals 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.