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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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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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
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
May 29, 2020 amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 9... 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, 1000 ta... 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, 1000 ta... 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, Bulk, Distribut... 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, Bulk, 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, 500 mg USP, 500 tabl... 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, 750 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, 750 mg, Rx only... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Amneal Pharmaceuticals of New York, LLC
May 27, 2020 Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 ... Failed Dissolution Specifications Class III Pfizer Inc.
May 14, 2020 Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ... Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-ter... Class III InvaGen Pharmaceuticals, Inc.
Apr 15, 2020 Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Di... CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... Class II Amneal Pharmaceuticals of New York, LLC
Apr 14, 2020 Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Com... Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain m... Class I MasterPharm LLC
Mar 30, 2020 Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Ph... Failed Impurities/Degradation Specification: Presence of unknown impurity observed. Class II Par Pharmaceutical Inc.
Mar 4, 2020 PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par... Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Pre... Class III Par Pharmaceutical Inc.
Feb 27, 2020 Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distri... Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The... Class II Pfizer Inc.
Feb 10, 2020 Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablet... Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiratio... Class III Par Pharmaceutical Inc.
Feb 7, 2020 Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only... Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may ... Class I Taro Pharmaceuticals U.S.A., Inc.
Feb 5, 2020 Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-c... Defective Container: products potentially could have been packaged in defective bottles, with a n... Class II Pfizer Inc.
Feb 5, 2020 Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-c... Defective Container: products potentially could have been packaged in defective bottles, with a n... Class II Pfizer Inc.
Feb 3, 2020 Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dos... Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects... Class II Pfizer Inc.
Feb 3, 2020 Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reduc... Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement... Class II Contract Pharmacal Corporation
Feb 3, 2020 Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reduce... Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement... Class II Contract Pharmacal Corporation
Dec 20, 2019 Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 9... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Denton Pharma, Inc.
Dec 20, 2019 Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 2... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Denton Pharma, Inc.
Dec 20, 2019 Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro P... Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. Class I Taro Pharmaceuticals U.S.A., Inc.
Nov 27, 2019 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only,... Labeling: Incorrect or Missing Lot and/or expiration date. Class II Pfizer Inc.
Nov 25, 2019 Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Pa... Failed Impurities/Degradation Specifications Class II Medisca, Inc.
Nov 25, 2019 VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 ... Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the pro... Class III Apothecus Pharmaceutical Corp.
Nov 22, 2019 Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).1... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).1... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Oct 16, 2019 Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10... Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. Class III Amneal Pharmaceuticals, 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.