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
Jul 27, 2020 Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distribut... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin ... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distrib... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., ... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distri... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distri... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count ... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distrib... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calv... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 24, 2020 VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate ... cGMP deviations Class II Vilvet Pharmaceuticals Inc.
Jul 24, 2020 VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosp... cGMP deviations Class II Vilvet Pharmaceuticals Inc.
Jul 23, 2020 scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcoh... CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... Class II Real Clean Distribuciones SA de CV
Jul 23, 2020 LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, ... CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... Class II Real Clean Distribuciones SA de CV
Jul 23, 2020 BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packa... CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... Class II Real Clean Distribuciones SA de CV
Jul 23, 2020 scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL... CGMP Deviations: Other products were recalled because they were manufactured in the same facility... Class II Real Clean Distribuciones SA de CV
Jul 21, 2020 Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrou... Failed Impurities/Degradation Specifications: Out of specification result observed in related sub... Class II Lupin Pharmaceuticals Inc.
Jul 20, 2020 Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose... Lack of Assurance of Sterility; potential loose metal overseal crimp defects. Class II Pfizer Inc.
Jul 17, 2020 Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Lim... Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle o... Class II Lupin Pharmaceuticals Inc.
Jul 16, 2020 HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biol... Labeling: Error on Declared Strength Class II Grato Holdings, Inc.
Jul 14, 2020 Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: A... Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not ... Class II Teva Pharmaceuticals USA
Jul 14, 2020 Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Dis... cGMP Deviations Class II Soluciones Cosmeticas, SA de CV
Jul 13, 2020 Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for... SUBPOTENT DRUG Class II Bausch Health Companies, Inc.
Jul 11, 2020 Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcoh... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packa... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Pack... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), pac... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost ... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 10, 2020 Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Man... cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufac... Class II Keryx Biopharmaceuticals, Inc.
Jul 9, 2020 Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottl... CGMP Deviations: Products manufactured at the same site were FDA testing found below the label cl... Class II Maquiladora Miniara Sa De Cv
Jul 7, 2020 Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 7, 2020 Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 7, 2020 Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 7, 2020 Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 3, 2020 Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bott... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Granules Pharmaceuticals Inc
Jul 2, 2020 Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richm... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Libert... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterP... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx o... Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples. Class II Lupin Pharmaceuticals Inc.
Jul 2, 2020 Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPh... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Finasteride Plus 1.25mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterP... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, Maste... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446... Labeling: Label Error on Declared Strength Class II Edge Pharma, LLC
Jul 2, 2020 Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPha... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm 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.