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 |
|---|---|---|---|---|
| Nov 15, 2024 | Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by... | Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 ... | Class II | Evaric Pharmaceuticals Inc. |
| Dec 11, 2023 | Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Ma... | CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. | Class II | Legacy Pharmaceutical Packaging LLC |
| Sep 24, 2020 | Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Man... | Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles. | Class III | Legacy Pharmaceutical Packaging LLC |
| Apr 24, 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found ... | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distrib... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 7, 2017 | ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The K... | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets ... | Class II | Legacy Pharmaceutical Packaging LLC |
| Apr 9, 2014 | Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10)... | Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Rele... | Class II | Legacy Pharmaceutical Packaging |
| Feb 14, 2014 | Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: W... | Chemical Contamination: The recalling firm received notice that their supplier is recalling capsu... | Class II | Legacy Pharmaceutical Packaging |
| Apr 22, 2013 | Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufact... | Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine ... | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 27, 2013 | Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceu... | Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 | Class III | Legacy Pharmaceutical Packaging 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.