Browse Drug Recalls

1,040 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,040 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 1,040 FDA drug recalls in NY.

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DateProductReasonClassFirm
Jun 8, 2015 ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Vaginal Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 5, 2015 Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (... CGMP Deviation: Poor container closure of the bulk storage container Class III Geritrex Corp
May 22, 2015 Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt... cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... Class II Blenheim Pharmacal, Inc.
May 22, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... Failed Stability Specification: out of specification result obtained for the Particle Size Distri... Class III Novartis Pharmaceuticals Corp.
May 22, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... Failed Stability Specification: out of specification result obtained for the Particle Size Distri... Class III Novartis Pharmaceuticals Corp.
May 22, 2015 Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA L... cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... Class II Blenheim Pharmacal, Inc.
May 21, 2015 SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: In... Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey ... Class II Medtech Products, Inc.
May 12, 2015 Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and l... CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer c... Class II Allegiant Health
Apr 10, 2015 MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-D... Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include on... Class III Medtech Products, Inc.
Mar 17, 2015 Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon W... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Welln... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Well... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellne... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Welln... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 300... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmac... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mc... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fal... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon We... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Feb 26, 2015 Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manuf... Failed Impurities/Degradation Specifications Class III Pfizer Inc.
Feb 26, 2015 Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufac... Failed Impurities/Degradation Specifications Class III Pfizer Inc.
Feb 12, 2015 Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams ste... Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene Class II Par Pharmaceutical Inc.
Dec 30, 2014 Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistami... Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup. Class II Taro Pharmaceuticals U.S.A., Inc.
Dec 19, 2014 B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutri... Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used f... Class II Bethel Nutritional Consulting, Inc
Dec 19, 2014 SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc. Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutra... Class I Bethel Nutritional Consulting, Inc
Dec 3, 2014 Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61... Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cra... Class II Pfizer Inc.
Nov 24, 2014 HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distr... Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydro... Class II Par Pharmaceutical Inc.
Oct 21, 2014 Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufact... Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was err... Class III Taro Pharmaceuticals U.S.A., Inc.
Oct 10, 2014 TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL an... Crystallization: Impurities in a raw material used to manufacture the diluent can cause the forma... Class III Pfizer Inc.
Aug 28, 2014 FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalm... Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet t... Class II Fougera Pharmaceuticals Inc.
Aug 25, 2014 Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, ... Failed Content Uniformity Specifications. Class III Taro Pharmaceuticals U.S.A., Inc.
Jul 30, 2014 Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, M... Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making... Class III Novartis Pharmaceuticals Corp.
Jul 30, 2014 Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL... Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval a... Class III Pfizer Inc.
Jul 17, 2014 Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, ... Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each m... Class III X-Gen Pharmaceuticals Inc.
Jul 9, 2014 Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Prep... cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... Class II Gyma Laboratories Of Amer,Inc
Jul 9, 2014 Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medi... cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... Class II Gyma Laboratories Of Amer,Inc
Jul 9, 2014 Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medici... cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... Class II Gyma Laboratories Of Amer,Inc
Jul 9, 2014 Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for ... cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... Class II Gyma Laboratories Of Amer,Inc
Jul 8, 2014 VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only... Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect ex... Class III Pfizer Inc.
Jul 3, 2014 Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatol... Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet s... Class III Fougera Pharmaceuticals Inc.
Jul 3, 2014 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermat... Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet s... Class III Fougera Pharmaceuticals Inc.
Jun 19, 2014 Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottl... Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications f... Class III Pfizer Inc.
Jun 6, 2014 DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorop... Stability Data Does Not Support Expiry Class III Estee Lauder Inc
May 28, 2014 Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule... Failed Stability Specification; out of specification result for particle size distribution during... Class III Novartis Pharmaceuticals Corp.
Apr 25, 2014 PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextrometh... Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Class III Prestige Brands Holdings
Apr 25, 2014 PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg an... Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Class III Prestige Brands Holdings
Apr 16, 2014 Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx ... Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended... Class II Pfizer Us Pharmaceutical Group

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.