Browse Drug Recalls
4 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 4 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 4 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 20, 2024 | Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured... | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... | Class III | Contract Pharmaceuticals Limited Canada |
| Aug 25, 2023 | Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/D... | Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,... | Class I | Marlex Pharmaceuticals, Inc. |
| Aug 25, 2023 | Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Di... | Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,... | Class II | Marlex Pharmaceuticals, Inc. |
| Aug 8, 2013 | Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Phar... | CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good ma... | Class II | Marlex 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.