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
Mar 15, 2022	Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams t...	cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ...	Class II	Teligent Pharma, Inc.
Mar 15, 2022	Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, ...	cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ...	Class II	Teligent Pharma, Inc.
Mar 15, 2022	Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Telig...	cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ...	Class II	Teligent Pharma, Inc.
Mar 15, 2022	Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only,...	cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ...	Class II	Teligent Pharma, Inc.
Mar 15, 2022	Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, M...	cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ...	Class II	Teligent Pharma, Inc.
Mar 14, 2022	PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a)...	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ...	Class II	Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022	TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Sin...	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ...	Class II	Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022	PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials ...	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ...	Class II	Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022	PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vial...	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ...	Class II	Vitae Enim Vitae Scientific, Inc.
Mar 10, 2022	ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solu...	CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specificatio...	Class II	Rock Town Distillery, Inc.
Mar 4, 2022	Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical...	CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu...	Class II	Direct Rx
Mar 4, 2022	Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical ...	CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu...	Class II	Direct Rx
Mar 3, 2022	HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/...	CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufac...	Class II	Tennessee Technical Coatings, Corp.
Mar 2, 2022	Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTR...	CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing ...	Class II	Golden State Medical Supply Inc.
Feb 22, 2022	Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per b...	CGMP deviations	Class II	Preferred Pharmaceuticals, Inc.
Feb 18, 2022	All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores ...	CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.	Class II	Dollar Tree Distribution, Inc.
Feb 16, 2022	Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: M...	cGmp Deviations	Class II	Macleods Pharma Usa Inc
Feb 15, 2022	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, ...	cGMP deviations	Class II	Macleods Pharma Usa Inc
Feb 15, 2022	Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-9...	cGMP Deviations	Class II	ANI Pharmaceuticals, Inc.
Feb 15, 2022	Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by...	cGMP Deviations	Class II	ANI Pharmaceuticals, Inc.
Feb 15, 2022	Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-9...	cGMP Deviations	Class II	ANI Pharmaceuticals, Inc.
Feb 15, 2022	Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-9...	cGMP Deviations	Class II	ANI Pharmaceuticals, Inc.
Feb 15, 2022	Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-...	cGMP Deviations	Class II	ANI Pharmaceuticals, Inc.
Feb 4, 2022	Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v an...	cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa...	Class II	Professional Disposables International, Inc.
Feb 4, 2022	Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w...	cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa...	Class II	Professional Disposables International, Inc.
Feb 4, 2022	Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3....	cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa...	Class II	Professional Disposables International, Inc.
Jan 26, 2022	DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packe...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufa...	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co...	Class II	CARDINAL HEALTHCARE
Jan 26, 2022	Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%,...	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co...	Class II	CARDINAL HEALTHCARE
Jan 26, 2022	Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) ...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratorie...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 5...	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co...	Class II	CARDINAL HEALTHCARE
Jan 26, 2022	Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Lab...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsul...	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co...	Class II	CARDINAL HEALTHCARE
Jan 26, 2022	Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per carton...	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co...	Class II	CARDINAL HEALTHCARE
Jan 26, 2022	Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, ...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratori...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lup...	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co...	Class II	CARDINAL HEALTHCARE
Jan 26, 2022	4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethor...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULT...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, I...	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co...	Class II	CARDINAL HEALTHCARE
Jan 26, 2022	Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrin...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby La...	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co...	Class II	CARDINAL HEALTHCARE
Jan 26, 2022	Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTR...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: A...	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co...	Class II	CARDINAL HEALTHCARE
Jan 26, 2022	APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laborator...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, UL...	CGMP Deviations	Class II	ULTRAtab Laboratories, Inc.
Jan 26, 2022	Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Conta...	CGMP Deviations	Class II	ULTRAtab Laboratories, 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.