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Browse Drug Recalls

16 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 16 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 16 FDA drug recalls.

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DateProductReasonClassFirm
May 19, 2023 Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharm... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals Inc
May 19, 2023 Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharm... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals Inc
May 19, 2023 Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals Inc
Feb 28, 2023 Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose ... Labeling: Not elsewhere classified Class II Sagent Pharmaceuticals Inc
Mar 11, 2021 Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial pac... Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may res... Class II Sagent Pharmaceuticals Inc
Apr 30, 2019 Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL V... Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufac... Class II Sagent Pharmaceuticals Inc
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Sin... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Sin... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Sing... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Jun 13, 2016 Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - ... Presence of Particulate Matter; The firm received two product complaints for small, dark particul... Class II Sagent Pharmaceuticals Inc
Mar 1, 2016 Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Sing... Cross contamination with other products: metronidazole Class II Sagent Pharmaceuticals Inc
Feb 23, 2015 Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5... Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic an... Class II Sagent Pharmaceuticals Inc
Feb 23, 2015 Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only,... Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic an... Class II Sagent Pharmaceuticals Inc
Oct 3, 2014 Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-... Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as... Class II Sagent Pharmaceuticals Inc
Mar 4, 2014 Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag... Lack of Assurance of Sterility; leaking of premix bags Class II Sagent Pharmaceuticals Inc
Jun 7, 2013 VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconsti... CGMP Deviations: product was not manufactured under current good manufacturing practices which co... Class II Sagent 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.