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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
Jul 31, 2014 CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx o... Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container clo... Class II Ben Venue Laboratories Inc
Feb 14, 2014 Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratorie... Presence of Particulate Matter: During a review of retain samples, the firm found a glass particu... Class I Ben Venue Laboratories Inc
Jul 5, 2012 Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, M... Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline... Class II Ben Venue Laboratories Inc
Jun 26, 2012 Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg... Presence of Particulate Matter Class I Ben Venue Laboratories Inc
May 1, 2012 Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 m... Short Fill: These products are being recalled because there is potential that vials with low fill... Class II Ben Venue Laboratories Inc
May 1, 2012 Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials,... Short Fill: These products are being recalled because there is potential that vials with low fill... Class II Ben Venue Laboratories 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.