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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
Oct 26, 2018 Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifes... Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability... Class III RemedyRepack Inc.
Sep 25, 2018 Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 360... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% ... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% ... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% D... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Jul 11, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... Failed Stability Specifications: lot out of specification for elevated water vapor. Class III Renaissance Lakewood, LLC
Jul 11, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 20... Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodiu... Class III Renaissance Lakewood, LLC
Jul 11, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. Class III Renaissance Lakewood, LLC
Feb 21, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmoti... Class II Renaissance Lakewood, LLC
Nov 6, 2017 Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, ... Superpotent Class III Claris Lifesciences Inc
Mar 10, 2017 Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Clari... Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... Class II Claris Lifesciences Inc
Mar 10, 2017 Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, ... Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... Class II Claris Lifesciences Inc
Mar 10, 2017 Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only... Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... Class II Claris Lifesciences Inc
Mar 10, 2017 Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Clar... Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... Class II Claris Lifesciences 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.