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Browse Drug Recalls

1,018 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,018 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 1,018 FDA drug recalls in NY.

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DateProductReasonClassFirm
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 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 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.
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 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 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.
Sep 9, 2020 Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces ... Labeling: Incorrect or Missing Package Insert: The package insert included in the finished produc... Class III P & L Developments, LLC
Aug 10, 2020 BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 Failed Impurity /Degradation Specifications Class II Par Pharmaceutical Inc.
Aug 3, 2020 Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine ... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Aug 3, 2020 Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Jul 31, 2020 Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 F... Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due ... Class III The Mentholatum Company
Jul 20, 2020 Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose... Lack of Assurance of Sterility; potential loose metal overseal crimp defects. Class II Pfizer Inc.
Jul 20, 2020 Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) ... Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... Class III Taro Pharmaceuticals U.S.A., Inc.
Jul 2, 2020 Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle,... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 3 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-0... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Libe... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 300 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Libert... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finast... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPha... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, Maste... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterP... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Finasteride Plus 1.25mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPh... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterP... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Libert... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richm... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jun 9, 2020 Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle,... Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and b... Class I MasterPharm LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only,... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only... Presence of Particulate Matter: particulate matter identified after reconstitution. Class II Pfizer Inc.
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only,... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 coun... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, 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.