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
Feb 7, 2023	rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: A...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle ND...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 167...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-4...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactur...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC ...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured f...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 1...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC ...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC ...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 1...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, ...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufacture...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets ...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Table...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for:...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured f...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets ND...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bot...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufact...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets ND...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Feb 7, 2023	Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured ...	CGMP Deviations: recalling drug products following an FDA inspection.	Class II	Accord Healthcare, Inc.
Jan 30, 2023	Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey...	CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th...	Class II	Global Pharma Healthcare Private Limited
Jan 30, 2023	Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i...	CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th...	Class II	Global Pharma Healthcare Private Limited
Jan 17, 2023	Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 M...	CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio...	Class II	Urban Electric Power
Jan 17, 2023	Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.	CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio...	Class II	Urban Electric Power
Jan 17, 2023	Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged...	CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ...	Class II	Fisher Scientific Co., LLC
Jan 17, 2023	Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 ...	CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ...	Class II	Fisher Scientific Co., LLC
Jan 12, 2023	Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose...	CGMP Deviations: potential for trace amounts of product carryover.	Class II	Nephron Sc Inc
Jan 12, 2023	0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Onl...	CGMP Deviations: potential for trace amounts of product carryover.	Class II	Nephron Sc Inc
Jan 10, 2023	Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle...	CGMP Deviations: initiated due to violations of CGMP manufacturing practices	Class II	Consolidated Chemical, Inc
Jan 10, 2023	Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Sai...	CGMP Deviations: initiated due to violations of CGMP manufacturing practices	Class II	Consolidated Chemical, Inc
Dec 22, 2022	Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular In...	CGMP Deviations: Raw material recalled by repackager, due to discoloration.	Class II	Pine Pharmaceuticals, LLC
Dec 15, 2022	Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 918...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Fr...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gall...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (1...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 m...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL...	cGMP Deviations	Class II	Frenda Corporation
Dec 12, 2022	Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g)...	cGMP Deviations	Class II	Atlantic Management Resources Ltd.
Dec 12, 2022	Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g...	cGMP Deviations	Class II	Atlantic Management Resources Ltd.
Dec 12, 2022	Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged...	cGMP Deviations	Class II	Atlantic Management Resources Ltd.
Dec 12, 2022	ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 ...	cGMP Deviations	Class II	Atlantic Management Resources Ltd.
Dec 9, 2022	Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution,...	CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess o...	Class II	NCH Life Sciences LLC
Dec 7, 2022	Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Phar...	CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.	Class II	Lupin Pharmaceuticals Inc.
Dec 7, 2022	Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Phar...	CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.	Class II	Lupin Pharmaceuticals Inc.
Nov 10, 2022	PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 5...	CGMP Deviations: Potential for cross contamination due to product carry over.	Class II	Nephron Sterile Compounding Center 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.