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Browse Drug Recalls

930 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 930 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 930 FDA drug recalls in 2020.

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DateProductReasonClassFirm
Dec 17, 2020 PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only,... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 16, 2020 Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx ... Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in... Class III US Compounding Inc
Dec 14, 2020 Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use On... cGMP deviations: Vials may not be sealed correctly affecting sterility. Class II CIPLA
Dec 14, 2020 Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dos... Subpotent drug. Class II SCA Pharmaceuticals, Inc.
Dec 10, 2020 Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 m... Subpotent Drug: Low out-of-specification assay results for the epinephrine component. Class II Fresenius Kabi USA, LLC
Dec 9, 2020 Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in... Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, ... Class II Morton Grove Pharmaceuticals, Inc.
Dec 9, 2020 Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufac... CGMP Deviations Class II Akebia Therapeutics dba Keryx Biopharmaceutials...
Dec 9, 2020 Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a... Failed dissolution specifications: out-of-specification test results observed during the buffer s... Class II Biogen MA Inc.
Dec 8, 2020 Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: ... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only,... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: ... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... CGMP Deviations Class II Shilpa Medicare Limited
Dec 7, 2020 Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, ... Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Inje... Class II Hikma Pharmaceuticals USA Inc.
Dec 7, 2020 Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: A... Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b... Class II AVKARE Inc.
Dec 7, 2020 TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manuf... Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b... Class I AVKARE Inc.
Dec 3, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablet... Failed Dissolution Specifications Class II Zydus Pharmaceuticals (USA) Inc
Dec 3, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets... Failed Dissolution Specifications Class II Zydus Pharmaceuticals (USA) Inc
Dec 1, 2020 Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. ... cGMP deviations: Product made at the same facility where product tested was sub-potent. Class II GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALI...
Dec 1, 2020 Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Mad... cGMP deviations: Product made at the same facility where product tested was sub-potent. Class II GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALI...
Nov 30, 2020 PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, India... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indi... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indi... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular ... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, India... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianap... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medi... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, ... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicin... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular M... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medic... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, I... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Ind... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medi... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indi... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, I... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 25, 2020 UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distribut... Subpotent drug Class II Simex Logistics SA de CV
Nov 25, 2020 Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distri... Subpotent drug Class II Simex Logistics SA de CV
Nov 25, 2020 Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed... Subpotent drug Class II Simex Logistics SA de CV
Nov 25, 2020 +Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% ... Subpotent drug Class II Simex Logistics SA de CV
Nov 25, 2020 CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81... Subpotent drug Class II Simex Logistics SA de CV
Nov 25, 2020 Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India f... Failed Dissolution Specifications Class I Torrent Pharma Inc
Nov 25, 2020 Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospit... Labelling: Missing label. Class III US Compounding Inc
Nov 24, 2020 Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by... Failed Dissolution Specifications; Out of Specification (low) results were obtained. Class II Ascend Laboratories LLC
Nov 23, 2020 Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (... Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specificat... Class II Ascend Laboratories LLC
Nov 20, 2020 HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodi... CGMP deviations: Lack of potency testing. Class II Complete Pharmacy and Medical Solutions, 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.