Browse Drug Recalls

1,720 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,720 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 1,720 FDA drug recalls, Class III.

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DateProductReasonClassFirm
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 18, 2014 Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manu... Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. Class III Apotex Corp.
Apr 17, 2014 Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-... Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long te... Class III Wockhardt Usa Inc.
Apr 17, 2014 Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trig... Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 mic... Class III Trigen Laboratories, Inc.
Apr 15, 2014 Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl an... Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. Class III P&L Developments, LLC
Apr 14, 2014 HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi... Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperid... Class III Fresenius Kabi USA LLC
Apr 14, 2014 Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorph... Subpotent Drug: Phenylephrine component is subpotent. Class III P&L Developments, LLC
Apr 14, 2014 Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufacture... Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the p... Class III Upsher Smith Laboratories, Inc.
Apr 11, 2014 Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dex... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Apr 9, 2014 Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufac... Failed Impurities/Degradation Specifications: out of specification results for impurities/degrada... Class III Caraco Pharmaceutical Laboratories, Ltd.
Apr 9, 2014 Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle... Failed Impurities/Degradation Specifications: out of specification results for impurities/degrada... Class III Caraco Pharmaceutical Laboratories, Ltd.
Apr 4, 2014 Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laborator... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... Class III Boehringer Ingelheim Roxane Inc
Apr 4, 2014 Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laborato... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... Class III Boehringer Ingelheim Roxane Inc
Apr 1, 2014 Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 F... Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone... Class III Genesis Pharmaceutical, Inc.
Apr 1, 2014 PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Kon... Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. Class III Konsyl Pharmaceuticals Inc
Mar 27, 2014 Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spi... Defective Delivery System: Potential for dose delivery out of specification due to interation of ... Class III Boehringer Ingelheim Roxane Inc
Mar 25, 2014 Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, R... Labeling; Missing label; ampoules are missing the immediate container label Class III Hospira Inc.
Mar 20, 2014 Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Ap... Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 mont... Class III Apotex Inc.
Mar 17, 2014 Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial... Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. Class III John W Hollis Inc
Mar 17, 2014 Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Ph... Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. Class III John W Hollis Inc
Mar 3, 2014 Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets ... Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. Class III McKesson Packaging Services
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.
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.
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 20, 2014 Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint F... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 coun... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combin... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Loze... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vi... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 coun... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Loze... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vi... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 coun... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count ... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 19, 2014 Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarat... Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug. Class III Gilead Sciences, Inc.
Feb 11, 2014 Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactur... Cross Contamination with Other Products: Product contains Promacta (eltrombopag). Class III Viiv Healthcare Company
Feb 11, 2014 QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cy... Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point Class III Teva Pharmaceuticals USA
Feb 10, 2014 Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx... Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than No... Class III Pinnacle Biologics Inc
Feb 7, 2014 Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use... Subpotent Drug: Drug potency was compromised during shipment. Class III Actavis
Feb 4, 2014 Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan ... Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenes... Class III Aaron Industries Inc
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical O... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oi... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, 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.

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.