Browse Drug Recalls
6 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6 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 6 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 26, 2014 | Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/cart... | Failed Dissolution Specification; at the 6-month stability time point | Class II | Forest Pharmaceuticals Inc |
| Jun 19, 2014 | Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bott... | Failed Dissolution Specifications: Drug failed stage III dissolution testing. | Class II | Forest Pharmaceuticals Inc |
| May 12, 2014 | Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed ... | Failed Dissolution Specifications: One lot of product is being voluntarily recalled because disso... | Class II | Forest Pharmaceuticals Inc |
| Nov 13, 2013 | Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) ext... | Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... | Class III | Forest Pharmaceuticals Inc |
| Nov 13, 2013 | Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, pa... | Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... | Class III | Forest Pharmaceuticals Inc |
| Nov 13, 2013 | Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, ... | Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... | Class III | Forest Pharmaceuticals 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.