Browse Drug Recalls

3,368 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,368 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 3,368 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Jan 24, 2022	Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bott...	cGMP deviations	Class II	Ultra Seal Corporation
Jan 24, 2022	Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, pa...	cGMP deviations	Class II	Ultra Seal Corporation
Jan 24, 2022	AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count pac...	cGMP deviations	Class II	Ultra Seal Corporation
Jan 24, 2022	PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 capl...	cGMP deviations	Class II	Ultra Seal Corporation
Jan 24, 2022	Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5...	cGMP deviations	Class II	Ultra Seal Corporation
Jan 24, 2022	ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium ...	cGMP deviations	Class II	Ultra Seal Corporation
Jan 24, 2022	PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b...	cGMP deviations	Class II	Ultra Seal Corporation
Jan 21, 2022	Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) top...	cGMP deficiencies	Class II	Mylan Pharmaceuticals Inc
Jan 14, 2022	Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY,...	CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.	Class II	Mayne Pharma Inc
Jan 11, 2022	Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The L...	cGMP deviations	Class II	Pharmasol Corporation
Jan 10, 2022	Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50)...	CGMP Deviations	Class II	Ingenus Pharmaceuticals Llc
Dec 30, 2021	Metformin 750 mg Extended Release NDC # 70518-2920-00	CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da...	Class II	RemedyRepack Inc.
Dec 27, 2021	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE ...	CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da...	Class II	VIONA PHARMACEUTICALS INC
Dec 6, 2021	Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenyleph...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% ...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL pe...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, ...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Ph...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Mul...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyl...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial ...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg...	CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not...	Class II	Medique Products
Dec 6, 2021	Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% /...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphoteri...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose C...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocor...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Contain...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syring...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID),...	CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not...	Class II	Medique Products
Dec 6, 2021	Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL pe...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injecti...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 ...	CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not...	Class II	Medique Products
Dec 6, 2021	Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottl...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Singl...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container...	CGMP Deviations	Class II	Edge Pharma, LLC
Dec 6, 2021	Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single D...	CGMP Deviations	Class II	Edge Pharma, LLC
Nov 29, 2021	PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coate...	CGMP Deviations: failed stability results, inadequate laboratory investigations,	Class II	ULTRAtab Laboratories, Inc.
Nov 23, 2021	Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deod...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company
Nov 23, 2021	Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Light Esse...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company
Nov 23, 2021	Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company
Nov 23, 2021	Secret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, To...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company
Nov 23, 2021	Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Ant...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company
Nov 23, 2021	Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chl...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company
Nov 23, 2021	Old Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%), Ant...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company
Nov 23, 2021	Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, C...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company
Nov 23, 2021	Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company
Nov 23, 2021	Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash ...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company
Nov 23, 2021	Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, ...	CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ...	Class II	The Procter & Gamble Company

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.