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
Aug 18, 2025 Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, ... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amneal Pharmaceuticals, LLC
Aug 18, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only,... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amneal Pharmaceuticals, LLC
Aug 18, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amneal Pharmaceuticals, LLC
Aug 18, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only,... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amneal Pharmaceuticals, LLC
Aug 13, 2025 Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in... Temperature Abuse Class II Sandoz Inc
Aug 12, 2025 Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical ... Discoloration Class II VIONA PHARMACEUTICALS INC
Aug 11, 2025 Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Dist... Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained... Class II Lannett Company Inc.
Aug 8, 2025 Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, R... CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. Class II Breckenridge Pharmaceutical, Inc.
Aug 8, 2025 Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manuf... Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by ... Class II Glenmark Pharmaceuticals Inc., USA
Aug 7, 2025 Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: G... CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... Class II Glenmark Pharmaceuticals Inc., USA
Aug 7, 2025 Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462... CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... Class II Glenmark Pharmaceuticals Inc., USA
Aug 7, 2025 Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by:... CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... Class II Glenmark Pharmaceuticals Inc., USA
Aug 6, 2025 Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured ... CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... Class II Westminster Pharmaceuticals LLC
Aug 6, 2025 Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured... CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... Class II Westminster Pharmaceuticals LLC
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 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 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 Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 28... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Semaglutide with B12 for Injection, all strengths and presentations, GenoGeni... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech... CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... Class II Cardinal Health Inc.
Jul 30, 2025 Sterile Saline Reconstitution Solution for Injection, all strengths and prese... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGeni... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL M... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Low Solubility Peptide Reconstitution Solution for Injection, all strengths a... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 L-Arginine HCl 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
Jul 30, 2025 Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and present... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC,... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South ... CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... Class II Cardinal Health Inc.
Jul 30, 2025 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intrave... Failed Impurities/Degradation Specifications: out of specification results for arsenic in the imp... Class II Exela Pharma Sciences LLC
Jul 30, 2025 L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations,... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW... 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 Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd... 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 B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 284... 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 Methylcobalamin for Injection, all strengths and presentations, GenoGenix... 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 Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths ... 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 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

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.