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Browse Drug Recalls

14,136 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,136 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 14,136 FDA drug recalls — Class II.

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DateProductReasonClassFirm
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 B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LL... 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 Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGe... 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 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 B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGeni... 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 Glutathione Preserved for Injection, all strengths and presentations, GenoGen... 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 Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LL... 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 Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 28... 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 L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 28... 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 Bacteriostatic Water for Injection, all strengths and presentations, GenoGeni... 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 Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 ... 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 Calcium Chloride for Injection, all strengths and presentations, GenoGenix, L... 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 Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... 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 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 N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix... 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 Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, ... 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 GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoG... 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 Reconstitution XO Solution for Injection, all strengths and presentations, Ge... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 29, 2025 Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... Class II Amerisource Health Services LLC
Jul 29, 2025 Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx onl... Subpotent drug Class II Pfizer
Jul 25, 2025 Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactur... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Alembic Pharmaceuticals Limited
Jul 25, 2025 Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, R... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Breckenridge Pharmaceutical, Inc.
Jul 22, 2025 BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chlori... Lack of Assurance of Sterility. Class II Taizhou Kangping Medical Science And Technology...
Jul 22, 2025 Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactur... Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds Class II Hikma Pharmaceuticals USA Inc.
Jul 21, 2025 Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per ca... cGMP Deviations Class II YANGZHOU YULOU PAPER PRODUCTS CO., LTD
Jul 21, 2025 Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton... Failed Dissolution Specifications: potential for delayed dissolution of the dose after administra... Class II Merck & Co. Inc
Jul 21, 2025 Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx... Failed Dissolution Specifications: low dissolution results Class II Ascend Laboratories, LLC
Jul 18, 2025 Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 u... Lack of Processing Controls. Class II AEQUITA PHARMACY
Jul 18, 2025 Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 u... Lack of Processing Controls. Class II AEQUITA PHARMACY
Jul 18, 2025 Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (... Lack of Processing Controls. Class II AEQUITA PHARMACY
Jul 18, 2025 Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 u... Lack of Processing Controls. Class II AEQUITA PHARMACY
Jul 18, 2025 Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 ... Lack of Processing Controls. Class II AEQUITA PHARMACY
Jul 18, 2025 Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL ... Lack of Processing Controls. Class II AEQUITA PHARMACY
Jul 18, 2025 Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50... Lack of Processing Controls. Class II AEQUITA PHARMACY
Jul 18, 2025 Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 un... Lack of Processing Controls. Class II AEQUITA PHARMACY
Jul 18, 2025 Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (... Lack of Processing Controls. Class II AEQUITA PHARMACY

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.