Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Aug 23, 2013 Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solu... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II JCB Labs LLC
Aug 23, 2013 Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 3... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II JCB Labs LLC
Aug 23, 2013 Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II JCB Labs LLC
Aug 23, 2013 Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Inje... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II JCB Labs LLC
Aug 23, 2013 Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Fre... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II JCB Labs LLC

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.