Browse Drug Recalls

14,572 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,572 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 14,572 FDA drug recalls, Class II.

Clear
DateProductReasonClassFirm
Aug 6, 2025 Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured... CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... Class II Glenmark Pharmaceuticals Inc., USA
Aug 6, 2025 Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactur... CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... Class II Glenmark Pharmaceuticals Inc., USA
Aug 5, 2025 Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Front... Presence of foreign substance: identified as aluminum. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Aug 5, 2025 Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled ... Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, cont... Class II Cardinal Health Inc.
Aug 4, 2025 Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), R... Lack of Assurance of Sterility. Class II PFIZER INC
Aug 4, 2025 Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distri... Lack of Assurance of Sterility. Class II PFIZER INC
Aug 4, 2025 Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Ste... Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. Class II B BRAUN MEDICAL INC
Aug 4, 2025 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, ... Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. Class II B BRAUN MEDICAL INC
Jul 30, 2025 Bacteriostatic Water for Injection, all strengths and presentations, GenoGeni... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Magnesium Chloride for Injection, all strengths and presentations, GenoGenix,... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGe... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 28... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGeni... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 28... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Calcium Chloride for Injection, all strengths and presentations, GenoGenix, L... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Reconstitution XO Solution for Injection, all strengths and presentations, Ge... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 28... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 284... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL mu... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LL... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Glutathione Preserved for Injection, all strengths and presentations, GenoGen... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentatio... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Glutathione Magnesium for Injection, all strengths and presentations, GenoGen... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, Geno... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 pH Buffered Reconstitution Solution for Injection, all strengths and presenta... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Take... CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... Class II Cardinal Health Inc.
Jul 30, 2025 Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Elite Stack Reconstitution Solution for Injection, all strengths and presenta... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LL... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoG... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 N... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC,... Lack of Assurance of Sterility Class II GenoGenix 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.