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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Date	Product	Reason	Class	Firm
Jul 24, 2020	Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-9...	Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ...	Class III	Golden State Medical Supply 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 24, 2020	VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate ...	cGMP deviations	Class II	Vilvet Pharmaceuticals Inc.
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 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	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%), 16.9 ...	Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol con...	Class I	Real Clean Distribuciones SA de CV
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 22, 2020	Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr....	Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.	Class III	West-Ward Columbus Inc
Jul 22, 2020	Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 m...	Cross Contamination with other products: trace amounts of lidocaine	Class I	Fresenius Kabi USA, LLC
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 21, 2020	DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only...	Superpotent Drug	Class I	Ferring Pharmaceuticals Inc
Jul 21, 2020	Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap...	Superpotent Drug	Class I	Ferring Pharmaceuticals Inc
Jul 21, 2020	STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with s...	Superpotent Drug	Class I	Ferring Pharmaceuticals Inc
Jul 20, 2020	OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L)...	Chemical Contamination: Products contain methanol and were below the label claim for ethanol content	Class I	Liq-E S.A. De C.V.
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 20, 2020	OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L)...	Chemical Contamination: Products contain methanol and were below the label claim for ethanol content	Class I	Liq-E S.A. De C.V.
Jul 20, 2020	OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) d...	Chemical Contamination: Products contain methanol and were below the label claim for ethanol content	Class I	Liq-E S.A. De C.V.
Jul 20, 2020	OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (...	Chemical Contamination: Products contain methanol and were below the label claim for ethanol content	Class I	Liq-E S.A. De C.V.
Jul 20, 2020	Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) ...	Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ...	Class III	Taro Pharmaceuticals U.S.A., 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	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 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 13, 2020	Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx on...	Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly sta...	Class III	Fresenius Kabi USA, LLC
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	blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) P...	Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th...	Class I	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 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 ...	Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th...	Class I	4e Brands North America, Llc
Jul 11, 2020	blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v...	Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th...	Class I	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	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 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 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	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 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	ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy...	Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV reg...	Class I	CareFusion 213, LLC
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	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v...	Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la...	Class I	CareFusion 213, LLC
Jul 7, 2020	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop...	Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la...	Class I	CareFusion 213, LLC
Jul 7, 2020	Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Ma...	Presence of Particulate Matter	Class I	Mylan Institutional LLC
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, 60 count bottle...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Lupin Pharmaceuticals Inc.
Jul 7, 2020	ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop...	Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV reg...	Class I	CareFusion 213, LLC
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 6, 2020	Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ...	Cross contamination with other products - OOS discovered during routine stability testing for hig...	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Jul 6, 2020	Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distr...	SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.	Class III	Allergan PLC
Jul 6, 2020	Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0...	SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.	Class III	Allergan PLC

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.