Browse Drug Recalls

3,371 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,371 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 3,371 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Jul 27, 2020	Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Cal...	CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po...	Class II	Calvin Scott & Company, Inc.
Jul 27, 2020	Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & ...	CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po...	Class II	Calvin Scott & Company, Inc.
Jul 27, 2020	Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags...	CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po...	Class II	Calvin Scott & Company, Inc.
Jul 27, 2020	Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & C...	CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po...	Class II	Calvin Scott & Company, Inc.
Jul 27, 2020	Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (20...	cGMP deviations	Class II	RESOURCE RECOVERY & TRADING LLC
Jul 27, 2020	HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ...	CGMP Deviations: products were recalled because they were manufactured in the same facility as th...	Class II	Broncolin, S.A. de C.V.
Jul 27, 2020	Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Cal...	CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po...	Class II	Calvin Scott & Company, Inc.
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 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 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 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 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 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	bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL...	CGMP Deviations	Class II	AAA Cosmetica, SA de CV
Jul 1, 2020	Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% to...	CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test ...	Class II	Preferred Pharmaceuticals, Inc.
Jun 25, 2020	Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distr...	CGMP Deviations: Product was found to be below the label claim for ethanol content and the presen...	Class II	POLARIZED LLC
Jun 23, 2020	Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bott...	cGMP deviations: one lot of the product was distributed to US Markets despite being rejected duri...	Class III	Biogen MA Inc.
Jun 17, 2020	Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage X...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce...	Class II	Preferred Pharmaceuticals, Inc.
Jun 12, 2020	Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (1...	CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established...	Class II	The Harvard Drug Group
Jun 11, 2020	Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Lupin Pharmaceuticals Inc.
Jun 5, 2020	Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Marksans Pharma Limited
Jun 5, 2020	metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	PD-Rx Pharmaceuticals, Inc.
Jun 5, 2020	metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	PD-Rx Pharmaceuticals, Inc.
Jun 4, 2020	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (ND...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	AVKARE Inc.
Jun 4, 2020	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	AVKARE Inc.

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.