Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
May 18, 2022 Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Lif... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Strides Pharma Inc.
May 18, 2022 Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syr... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 17, 2022 AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment Wit... cGMP deviations: product stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
May 17, 2022 AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g) cGMP deviations: product stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
May 17, 2022 Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. ... cGMP deviations: product stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
May 17, 2022 Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emol... cGMP deviations: product stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
May 17, 2022 Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Al... cGMP deviations: product stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
May 17, 2022 Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Mois... cGMP deviations: product stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
May 17, 2022 AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g) cGMP deviations: product stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
May 13, 2022 Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, O... 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 Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington ... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Dist... CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. Class II Direct Rx
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 Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Ho... 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 13, 2022 Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washin... cGMP deviations Class II Washington Homeopathic Products, Inc.
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 Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, W... 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 Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington ... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Hom... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Hom... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15... cGMP deviations Class II Washington Homeopathic Products, Inc.
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 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 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 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 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 Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharma... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olymp... 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 Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuti... 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 NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuti... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Package... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceu... 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

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.