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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.