Browse Drug Recalls
13 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 13 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 13 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 6, 2025 | Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured ... | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... | Class II | Westminster Pharmaceuticals LLC |
| Aug 6, 2025 | Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured... | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... | Class II | Westminster Pharmaceuticals LLC |
| Sep 28, 2021 | Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC:... | Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... | Class III | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Oct 29, 2018 | Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen P... | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... | Class II | Westminster Pharmaceuticals Llc |
| Oct 29, 2018 | Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen P... | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... | Class II | Westminster Pharmaceuticals Llc |
| Oct 29, 2018 | Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Ph... | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... | Class II | Westminster Pharmaceuticals Llc |
| Oct 29, 2018 | Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Aug 3, 2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100... | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... | Class I | Westminster Pharmaceuticals LLC |
| Aug 3, 2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100... | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... | Class I | Westminster Pharmaceuticals LLC |
| Aug 3, 2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg),... | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... | Class I | Westminster Pharmaceuticals LLC |
| Aug 3, 2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-... | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... | Class I | Westminster Pharmaceuticals LLC |
| Aug 3, 2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-c... | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... | Class I | Westminster 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.