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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
May 27, 2015 E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil po... Failed stability specifications:This recall has been initiated due to out of specification result... Class III Bracco Diagnostic Inc
Sep 18, 2014 E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -c... Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months. Class III Bracco Diagnostic Inc
Jul 2, 2014 E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manu... Subpotent Drug: Low out of specification results for both pH and assay obtained during routine st... Class III Bracco Diagnostic 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

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.