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Browse Drug Recalls

14 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14 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 14 FDA drug recalls.

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DateProductReasonClassFirm
Feb 9, 2024 HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 bli... an out of specification result obtained during routine stability testing for Impurities. There i... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
May 21, 2019 PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx On... Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... Class I Heritage Pharmaceuticals, Inc.
May 21, 2019 AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only,... Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... Class I Heritage Pharmaceuticals, Inc.
May 3, 2019 Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manuf... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Heritage Pharmaceuticals, Inc.
May 3, 2019 Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Ma... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Heritage Pharmaceuticals, Inc.
May 3, 2019 Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufa... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Heritage Pharmaceuticals, Inc.
May 3, 2019 Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured b... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Heritage Pharmaceuticals, Inc.
May 3, 2019 Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured b... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Heritage Pharmaceuticals, Inc.
Feb 15, 2019 Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only,... Subpotent Drug. Class II Heritage Pharmaceuticals, Inc.
Jan 2, 2019 Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, ... Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle Class II Heritage Pharmaceuticals, Inc.
Oct 15, 2018 Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only,... Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle Class II Heritage Pharmaceuticals, Inc.
Mar 25, 2015 GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bot... Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. Class II Heritage Pharmaceuticals, Inc.
Feb 25, 2015 RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcu... Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with qu... Class II Heritage Pharmaceuticals, Inc.
Feb 25, 2015 Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by:... Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with qu... Class II Heritage 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.