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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Date	Product	Reason	Class	Firm
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
Apr 1, 2014	HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (4...	Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown...	Class II	Hi-Tech Pharmacal Co., Inc.
Mar 25, 2014	Esmeralda, bottle contains 30 Softgels, product is packaged in a white plasti...	Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER...	Class I	New Life Nutritional Center
Mar 25, 2014	New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product i...	Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER...	Class I	New Life Nutritional Center
Mar 25, 2014	MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged ...	Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER...	Class I	New Life Nutritional Center
Mar 6, 2014	Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a...	Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg ca...	Class I	Pfizer Us Pharmaceutical Group
Mar 3, 2014	Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only...	Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the P...	Class III	Novartis Pharmaceuticals Corp.
Mar 3, 2014	Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only...	Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the P...	Class III	Novartis Pharmaceuticals Corp.
Feb 26, 2014	Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 cou...	Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphe...	Class III	Pfizer Us Pharmaceutical Group
Feb 14, 2014	CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals...	Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrullin...	Class I	Medisca Inc
Jan 29, 2014	GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, ...	Defective Container: Tamper evident ring failures discovered on some bottles.	Class II	Pfizer Inc.
Jan 29, 2014	Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E...	Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% ra...	Class III	Fougera Pharmaceuticals Inc.
Jan 22, 2014	Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per...	Subpotent; 18 month time point	Class II	Fresenius Kabi USA, LLC
Jan 16, 2014	ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, N...	Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh...	Class II	The Mentholatum Co.
Jan 16, 2014	ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops,...	Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh...	Class II	The Mentholatum Co.
Jan 16, 2014	ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile,...	Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh...	Class II	The Mentholatum Co.
Jan 16, 2014	ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL...	Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh...	Class II	The Mentholatum Co.
Jan 16, 2014	ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent...	Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh...	Class II	The Mentholatum Co.
Jan 2, 2014	Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I....	Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of spec...	Class III	Pfizer Inc.
Nov 18, 2013	KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division o...	Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.	Class III	Fougera Pharmaceuticals Inc.
Nov 4, 2013	Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, R...	Failed Dissolution Specification; 8 hr stability timepoint	Class III	Pfizer Inc.
Oct 28, 2013	Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx onl...	Failed Stability Specification; product viscosity and or pH are below specification.	Class III	Hi-Tech Pharmacal Co., Inc.
Oct 16, 2013	Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharm...	Subpotent. drug	Class III	Taro Pharmaceuticals U.S.A., 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.