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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
May 13, 2022 Morbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liqu... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washi... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washi... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pell... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington ... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liqu... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, W... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Wash... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 11, 2022 Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class II Direct Rx
May 11, 2022 Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distribute... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class II Direct Rx
May 11, 2022 Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in... Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability tes... Class I Teva Pharmaceuticals USA Inc
May 11, 2022 Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distribut... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class II Direct Rx
May 11, 2022 Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solutio... CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II A.P. Nonweiler
May 10, 2022 Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Contai... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corporation
May 10, 2022 Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Con... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corporation
May 10, 2022 Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corporation
May 10, 2022 Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plas... Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha... Class II AMS Packaging Inc
May 10, 2022 Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corporation
May 9, 2022 Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 m... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceut... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dos... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Mangan... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamin... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pha... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Ol... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atro... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmac... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL R... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanoba... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, package... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia P... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Ph... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only,... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Package... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympi... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia 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.