Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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DateProductReasonClassFirm
Apr 14, 2014 LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactur... Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning Class II Golden State Medical Supply Inc.
Apr 14, 2014 phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufact... Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside... Class II Fresenius Medical Care Holdings, Inc.
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 10, 2014 Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube p... Crystallization: Crystal precipitate formation and an increase in the number of complaints associ... Class II Bausch & Lomb, Inc.
Apr 10, 2014 Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in... Crystallization: Crystal precipitate formation and an increase in the number of complaints associ... Class II Bausch & Lomb, Inc.
Apr 10, 2014 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle,... Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. Class II Wockhardt Usa 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 9, 2014 Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10)... Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Rele... Class II Legacy Pharmaceutical Packaging
Apr 9, 2014 Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, ... Lack of Assurance of Sterility: A particle excursion for a different batch of the same product ma... Class II Caraco Pharmaceutical Laboratories, Ltd.
Apr 9, 2014 THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Coun... Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. Class I Nature's Universe
Apr 8, 2014 Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfi... Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discover... Class II Pfizer Inc.
Apr 7, 2014 Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manuf... Failed pH Specifications: product was too acidic. Class II Piramal Critical Care, Inc.
Apr 7, 2014 BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx on... Failed Impurities/Degradation Specifications: High out of specification impurity test results wer... Class II Teva Pharmaceuticals USA
Apr 7, 2014 BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx on... Failed Impurities/Degradation Specifications: High out of specification impurity test results wer... Class II Teva Pharmaceuticals USA
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 2, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administr... Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during ... Class I Hospira Inc.
Apr 1, 2014 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, R... Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. Class II Wockhardt Usa Inc.
Apr 1, 2014 triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP... Failed Impurities/Degradation Specifications: This recall is due to out of specification for impu... Class II Teva Pharmaceuticals USA
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 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.
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 28, 2014 AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongw... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineerin... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four ... Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso ... Class II United Therapeutics Corp.
Mar 28, 2014 Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orl... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orland... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los ... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Sp... Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 27, 2014 Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Singl... Presence of Particulate; red and black particulate within the solution and embedded within the pl... Class II Hospira 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 26, 2014 Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per... Superpotent Drug: Product contains twice the stated amount of midazolam. Class I Pharmakon Pharmaceuticals
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 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 Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FA... First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First A... Class II First Aid Only 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 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 24, 2014 Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Ma... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In ... CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Class II Teva Pharmaceuticals USA
Mar 24, 2014 PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In IN... CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Class II Teva Pharmaceuticals USA
Mar 24, 2014 Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex 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.