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.

Date	Product	Reason	Class	Firm
Nov 20, 2020	Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceutic...	Subpotency: Out-of-specification stability test result for low potency was obtained.	Class III	SCA Pharmaceuticals
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 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	Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), p...	Labeling: Label mix-up	Class III	Novocol Pharmaceutical of Canada, Inc.
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 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 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 18, 2020	Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, M...	Failed Dissolution Specifications: Out of specification for dissolution.	Class II	The Harvard Drug Group
Nov 18, 2020	Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and...	Marketed without an Approved NDA/ANDA: Product marketed with drug claims.	Class II	Fusion Health and Vitality LLC
Nov 17, 2020	H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0....	Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020	Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg...	Cross Contamination with other products: trace amounts of lidocaine	Class I	Fresenius Kabi USA, LLC
Nov 17, 2020	REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (...	Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated wit...	Class I	MPM Medical LLC
Nov 17, 2020	Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) ...	Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020	Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (2...	Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020	Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), D...	Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020	Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 ...	Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020	Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in...	Cross contamination: the excipient was found to be contaminated with theophylline.	Class II	BASF Corporation
Nov 17, 2020	ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, M...	FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits f...	Class II	Golden State Medical Supply Inc.
Nov 17, 2020	CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET ...	Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020	Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT ...	Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020	DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill...	Cross Contamination with Other Products: trace amounts of octreotide found during testing	Class III	Fresenius Kabi USA, LLC
Nov 17, 2020	RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W...	Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020	TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal,...	Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020	Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0...	Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Nov 11, 2020	Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, ...	Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5...	Class III	InvaTech Pharma Solutions, LLC
Nov 11, 2020	Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose ...	Superpotent Drug: High out-of-specification assay results were obtained during stability testing.	Class III	Teva Pharmaceuticals USA
Nov 11, 2020	Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, ND...	Failed Dissolution Specifications: Out of specification for dissolution.	Class II	Apotex Corp.
Nov 10, 2020	Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Man...	Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle o...	Class II	EYWA PHARMA INC
Nov 6, 2020	clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Man...	Failed Tablet/Capsule Specification	Class II	Jubilant Cadista Pharmaceuticals, Inc.
Nov 5, 2020	Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent...	Superpotent and Subpotent; low and high assay results	Class III	Teligent Pharma, Inc.
Nov 3, 2020	Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, ...	Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Inje...	Class II	Hikma Pharmaceuticals USA Inc.
Nov 3, 2020	Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only,...	Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.	Class III	Teligent Pharma, 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 30, 2020	Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bo...	Failed Dissolution Specifications	Class II	AVKARE Inc.
Oct 28, 2020	Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 m...	Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer ...	Class I	Lohxa LLC
Oct 28, 2020	Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx ...	Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during ...	Class II	Teva Pharmaceuticals USA
Oct 27, 2020	Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count c...	Failed Dissolution Specification	Class II	Zydus Pharmaceuticals (USA) Inc
Oct 27, 2020	Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count c...	Failed Dissolution Specification	Class II	Zydus Pharmaceuticals (USA) Inc
Oct 27, 2020	Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only...	Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.	Class I	Sunstar Americas, Inc.
Oct 26, 2020	Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count b...	Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablet...	Class II	Ascent Pharmaceuticals, Inc.
Oct 26, 2020	Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) bli...	Subpotent	Class III	Jubilant Cadista Pharmaceuticals, 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 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	Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Dis...	Failed impurities/ degradation specifications: Out of specification impurity results were observe...	Class III	Heritage Pharmaceuticals Inc
Oct 22, 2020	Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL ...	Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.	Class III	Aurobindo Pharma USA Inc.
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 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	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 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.

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.