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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
Apr 13, 2022 Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), pac... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Mar 8, 2018 E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Ma... Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - met... Class II Bracco Diagnostics Inc.
Dec 16, 2013 VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx On... Failed Stability Testing: This product is below specification for preservative content. Class III Bracco Diagnostics Inc
Jul 19, 2013 Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (... Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibit... Class III Bracco Diagnostics Inc
Jun 21, 2013 Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37... Presence of foreign substance: One lot of the product may contain black foreign particles Class II Bracco Diagnostics Inc
Nov 21, 2012 Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector S... Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Class I Bracco Diagnostic Inc
Nov 21, 2012 Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66... Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Class I Bracco Diagnostic Inc
Aug 14, 2012 Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials ... Presence of Particulate Matter; potential for charcoal particulates Class III Bracco Diagnostic Inc
Jun 1, 2012 CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution... GMP deviation; Sr-82 levels exceeded alert limit specification Class II Bracco Diagnostics Inc
Apr 16, 2012 Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy ... Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap du... Class II Bracco Diagnostics Inc
Apr 16, 2012 Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, ... Short Fill: The product is being recalled due to a potential underfill of the affected vials. Class III Bracco Diagnostics 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.