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 |
|---|---|---|---|---|
| Apr 13, 2022 | Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG:... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2018 | Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa... | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... | Class II | Prescript Pharmaceuticals, Inc. |
| May 15, 2015 | MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37... | Labeling: incorrect or missing lot number and/or expiration date | Class II | Mallinckrodt, Inc. |
| Jul 30, 2012 | Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solutio... | Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels... | Class III | Mallinckrodt Inc |
| May 25, 2012 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 ... | Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone ... | Class III | Mallinckrodt Inc. |
| May 25, 2012 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 ... | CGMP Deviations: This product is being recalled because expired flavoring was used in the manufac... | Class II | Mallinckrodt 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.