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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Browse Drug Recalls

1,034 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,034 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 1,034 FDA drug recalls in NY.

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DateProductReasonClassFirm
Aug 13, 2021 Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 t... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfi... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 10, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Lack of Assurance of Sterility Class II SterRx, LLC
Aug 10, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Non-Sterility: firm's third party lab confirmed microbial contamination. Class I SterRx, LLC
Jul 7, 2021 Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 5... Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the ... Class III LNK International, Inc.
Jun 16, 2021 Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottl... cGMP deviations: Discolored acetaminophen Class II Spirit Pharmaceuticals
Jun 9, 2021 Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... Class II Pfizer Inc.
Jun 9, 2021 Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfiz... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... Class II Pfizer Inc.
Jun 9, 2021 Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pf... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
May 3, 2021 Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx onl... Presence of Particulate Matter: particulate matter identified as an insect in one vial. Class II Pfizer Inc.
Apr 8, 2021 Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or ta... Class I NSNY Distributor Inc
Apr 8, 2021 Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Ang... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or ta... Class I NSNY Distributor Inc
Mar 19, 2021 Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, M... Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological ... Class II X-Gen Pharmaceuticals Inc.
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.
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 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 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

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.