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
Mar 10, 2021	aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, pa...	CGMP deviations: Product being recalled as it was made in the same facility where contamination w...	Class II	China Gel Inc
Mar 10, 2021	Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes...	CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the sa...	Class II	Sanit Technologies, LLC dba Durisan
Mar 2, 2021	Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Pac...	cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently tak...	Class II	Direct Rx
Jan 25, 2021	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets pe...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	Nostrum Laboratories Inc
Jan 22, 2021	Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx O...	CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si...	Class II	Ascend Laboratories LLC
Jan 22, 2021	Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx On...	CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si...	Class II	Ascend Laboratories LLC
Jan 8, 2021	Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmac...	CGMP deviations.	Class II	Taro Pharmaceuticals U.S.A., Inc.
Jan 4, 2021	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets pe...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	Nostrum Laboratories Inc
Jan 1, 2021	Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit ...	cGMP deviations: The firm was notified of the manufacturer's expanded recall.	Class II	Precision Dose Inc.
Dec 28, 2020	Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only...	cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia...	Class II	Sunstar Americas, Inc.
Dec 23, 2020	IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottl...	CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled...	Class II	Shane Erickson Inc
Dec 23, 2020	IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Mad...	CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled...	Class II	Shane Erickson Inc
Dec 23, 2020	IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Ma...	CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled...	Class II	Shane Erickson Inc
Dec 14, 2020	Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use On...	cGMP deviations: Vials may not be sealed correctly affecting sterility.	Class II	CIPLA
Dec 9, 2020	Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufac...	CGMP Deviations	Class II	Akebia Therapeutics dba Keryx Biopharmaceutials...
Dec 8, 2020	Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O...	CGMP Deviations	Class II	Shilpa Medicare Limited
Dec 8, 2020	Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: ...	CGMP Deviations	Class II	Shilpa Medicare Limited
Dec 8, 2020	Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O...	CGMP Deviations	Class II	Shilpa Medicare Limited
Dec 8, 2020	Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only,...	CGMP Deviations	Class II	Shilpa Medicare Limited
Dec 8, 2020	Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must...	CGMP Deviations	Class II	Shilpa Medicare Limited
Dec 8, 2020	Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: ...	CGMP Deviations	Class II	Shilpa Medicare Limited
Dec 1, 2020	Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Mad...	cGMP deviations: Product made at the same facility where product tested was sub-potent.	Class II	GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALI...
Dec 1, 2020	Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. ...	cGMP deviations: Product made at the same facility where product tested was sub-potent.	Class II	GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALI...
Nov 20, 2020	HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodi...	CGMP deviations: Lack of potency testing.	Class II	Complete Pharmacy and Medical Solutions, LLC.
Nov 20, 2020	HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sod...	CGMP deviations: Lack of potency testing.	Class II	Complete Pharmacy and Medical Solutions, LLC.
Nov 20, 2020	HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodi...	CGMP deviations: Lack of potency testing.	Class II	Complete Pharmacy and Medical Solutions, LLC.
Nov 20, 2020	HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodi...	CGMP deviations: Lack of potency testing.	Class II	Complete Pharmacy and Medical Solutions, LLC.
Nov 19, 2020	CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Di...	Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.	Class II	US Pharmaceuticals Inc.
Nov 19, 2020	Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-D...	CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product f...	Class II	Areva Pharmaceuticals Inc
Nov 1, 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.
Oct 23, 2020	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	Nostrum Laboratories Inc
Oct 23, 2020	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottl...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	Nostrum Laboratories Inc
Oct 21, 2020	Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. M...	CGMP Deviations	Class II	H & H Remedies, LLC
Oct 21, 2020	White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold...	CGMP Deviations	Class II	H & H Remedies, LLC
Oct 21, 2020	Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 1...	CGMP Deviations	Class II	H & H Remedies, LLC
Oct 12, 2020	Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Daw...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	Direct Rx
Oct 11, 2020	Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx o...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	RemedyRepack Inc.
Oct 8, 2020	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (ND...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	Denton Pharma, Inc.
Oct 8, 2020	Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottl...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	Denton Pharma, Inc.
Oct 6, 2020	metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Ok...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	PD-Rx Pharmaceuticals, Inc.
Oct 6, 2020	metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: ...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	PD-Rx Pharmaceuticals, Inc.
Oct 2, 2020	Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	Marksans Pharma Limited
Oct 2, 2020	Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 ...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	Marksans Pharma Limited
Sep 24, 2020	SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL O...	CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled...	Class II	AA PRODUCTS INC
Sep 23, 2020	RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500...	CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.	Class II	SUN PHARMACEUTICAL INDUSTRIES INC
Sep 17, 2020	Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), L...	CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured ...	Class II	PD-Rx Pharmaceuticals, Inc.
Sep 11, 2020	Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon ...	CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit...	Class II	Genesis Partnership Company SA
Sep 11, 2020	Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guate...	CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit...	Class II	Genesis Partnership Company SA
Sep 11, 2020	Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8...	CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit...	Class II	Genesis Partnership Company SA
Sep 3, 2020	bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle...	CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed...	Class II	AJR TRADING 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.