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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
Feb 23, 2023 Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron... CGMP Deviations: Potential product carryover. Class II Nephron Sc Inc
Jan 13, 2023 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine,... Short Fill Class II Nephron Sc Inc
Jan 13, 2023 S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Ste... Short Fill Class II Nephron Sc Inc
Jan 12, 2023 Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose... CGMP Deviations: potential for trace amounts of product carryover. Class II Nephron Sc Inc
Jan 12, 2023 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Onl... CGMP Deviations: potential for trace amounts of product carryover. Class II Nephron Sc Inc
Aug 10, 2022 Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... cGMP Deviations: deviations leading to potential cross-contamination. Class II Nephron Sc 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.