Drug Recalls
A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market.
The list below includes voluntary recalls in which public notification has been issued.
See FDA’s role in drug recalls for more information.
See recalls for all FDA-regulated products.
For recall notices older than 60 days, see recall and safety alerts archive.
| Date | Brand Name | Product Description | Reason/ Problem | Company | ||
|---|---|---|---|---|---|---|
| 01/08/2019 | Sun Pharma | Vecuronium Bromide for Injection | Particulate matter | Sun Pharmaceutical Industries, Inc. | ||
| 01/05/2019 | Lupin Pharmaceuticals, Inc. | Ceftriaxone for Injection, USP | Due to products contain visual grey particulate matter in reconstituted vial | Lupin Pharmaceuticals, Inc. | ||
| 01/03/2019 | Torrent Pharmaceuticals Limited | Losartan potassium tablets, USP | due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) | Torrent Pharmaceuticals Limited | ||
| 12/31/2018 | Aurobindo | Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP | Undeclared N-nitrosodiethylamine (NDEA) | Aurobindo Pharma USA, Inc. | ||
| 12/31/2018 | Lubrisine | Eye Drops | Undeclared colloidal silver and lack of sterility assurance | Results RNA LLC | ||
| 12/20/2018 | Terrific Care LLC dba MedEx Supply | Roche CoaguChek test strips | inaccurately reports high INR test results. | Terrific Care, LLC. / Medex Supply Dist, Inc. | ||
| 12/20/2018 | Torrent Pharmaceuticals Limited | Losartan potassium tablets, USP | due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) | Torrent Pharmaceuticals Limited | ||
| 12/18/2018 | Puritan Bennett™ | Puritan Bennett™ 980 (PB980) ventilator series | Software update | Medtronic | ||
| 12/17/2018 | Envoachem Pharmaceuticals | Dyural-40 and Dyural-80 Convenience Kits Containing Sodium Chloride Injection, USP, 0.9% | Due to latex hazard/product labeling incorrectly states do not contain latex | Asclemed USA Inc dba Envoachem Pharmeceuticals | ||
| 12/11/2018 | Kotex | Tampons | Performance defect | Kimberly-Clark | ||
| 12/05/2018 | Family Wellness, CVS, Equate | Infants’ Ibuprofen | Products may have higher concentrations of Ibuprofen | Tris Pharma | ||
| 12/04/2018 | Mylan | Valsartan-containing products | Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient | Mylan Pharmaceuticals | ||
| 11/27/2018 | Teva Pharmaceuticals | Amlodipine/Valsartan Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination Tablets | Impurity N-nitroso-diethylamine (NDEA) in API | Teva Pharmaceuticals | ||
| 11/20/2018 | Mylan | Amlodipine and Valsartan Tablets; Valsartan Tablets; Valsartan and Hydrochlorothiazide Tablets | Contain trace amounts of an impurity, N-nitrosodiethylamine (NDEA) | Mylan Pharmaceuticals | ||
| 11/20/2018 | Fresenius Kabi | Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial | Labeling incorrectly states stoppers do not contain latex | Fresenius Kabi USA | ||
| 11/12/2018 | Oscor | Temporary Bipolar Pacing Lead, Model TB | Connector cap housing may slide and potentially expose the connection wire. | Oscor Inc. | ||
| 11/08/2018 | Losartan | Losartan Potassium Hydrochlorothiazide | Product contains NDEA impurity | Sandoz Inc | ||
| 11/07/2018 | Puriton | Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle | Non-Sterile Production Conditions | Kadesh Inc. | ||
| 11/02/2018 | ORTHO-NOVUM | ORTHO-NOVUM 1/35 and 7/7/7 (norethindrone / ethinyl estradiol) Tablets | does not include the appropriate instructions for the Veridate dispenser. | Janssen Pharmaceuticals, Inc. | ||
| 10/30/2018 | WP Westminster, more | Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms | due to the presence of an impurity, N-nitrosodiethylamine (NDEA) | ScieGen Pharmaceuticals, Inc | ||
| 10/26/2018 | Aurobindo Pharma Limited | Irbesartan Drug | Due to the presence of an impurity, N-nitrosodiethylamine (NDEA) | Aurobindo Pharma Limited | ||
| 10/22/2018 | Promise Pharmacy | Prednisolone and Gatifloxacin Ophthalmic Solution | Unidentified small particulate floating in the solution | Promise Pharmacy | ||
| 10/15/2018 | Zero Xtreme | Dietary Supplement for Weight Loss | Undeclared Sibutramine | Fat Burners Zone | ||
| 10/10/2018 | ReGen Series | All ReGen Series products | Adverse reactions | Liveyon, LLC | ||
| 10/09/2018 | Sprayology | Homeopathic Aqueous-Based Medicines | Possible microbial contamination | Eight and Company LLC, dba Sprayology | ||
| 10/03/2018 | Pet Alive, Native Remedies, Healthful Naturals | Homeopathic Drug Products (liquid) | Microbial Contamination | Silver Star Brands, Inc. | ||
| 09/28/2018 | Endo Pharmaceuticals | Robaxin® (methocarbamol tablets, USP) 750mg Tablets | Due to Incorrect Daily Dosing Information on Label | Endo Pharmaceuticals | ||
| 09/12/2018 | NeoRelief | Muscle | Due to possible microbial contamination | BioLyte Laboratories | ||
| 09/10/2018 | Pharm D Solutions | Compounded drugs | Lack of Sterility Assurance | Pharm D Solutions LLC | ||
| 09/06/2018 | SCA Pharmaceuticals | Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag | visible particulate matter | SCA Pharmaceuticals LLC (“SCA Pharma”) | ||
| 09/05/2018 | Camber Pharmaceuticals | Montelukast Sodium Tablets, USP 10mg | Product label mix up/may contain Losartan Potassium Tablets | Camber Pharmaceuticals, Inc | ||
| 09/05/2018 | Beaumont Bio Med Homeopathic | Homeopathic oral sprays | Microbial contamination | Beaumont Bio Med, Inc. | ||
| 08/29/2018 | Neuroveen, Respitrol, Thyroveev, Compulsin | Homeopathic Medicines | Possible Microbial Contamination | HelloLife, Inc. | ||
| 08/29/2018 | CyPass | Micro-Stent | Significant endothelial cell loss | Alcon | ||
| 08/28/2018 | CVS, Rhinall, Humist, more | Nasal Products and Baby Oral Gels | Pseudomonas aeruginosa contamination | Product Quest Manufacturing LLC | ||
| 08/27/2018 | Accord | Hydrochlorothiazide Tablets USP 12.5 mg | Labeling mix-up/may contain Spironolactone Tablets | Accord Healthcare Inc. | ||
| 08/27/2018 | Children’s Advil | Ibuprofen Oral Suspension | Dosage cup has incorrect measurement markings | Pfizer, Inc. | ||
| 08/23/2018 | Torrent Pharmaceuticals Limited | Valsartan/Amlodipine/HCTZ; Valsartan/Amlodipine; and Valsartan tablets | Impurity detected in the API is N-nitrosodimethylamine (NDMA) | Torrent Pharmaceuticals Limited | ||
| 08/22/2018 | KB, DK, more | Homeopathic products | Microbial contamination | King Bio | ||
| 08/17/2018 | Torrent | Valsartan/Amlodipine/HCTZ Tablets | Impurity detected in the API is N-nitrosodimethylamine (NDMA) | Torrent Pharmaceuticals | ||
| 08/13/2018 | Blissful Remedies | Products Containing Kratom | High microbial load | World Organix, LLC | ||
| 08/09/2018 | Westminster Pharmaceuticals, LLC | Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg | Risk of Adulteration | Westminster Pharmaceuticals, LLC | ||
| 08/08/2018 | CVS Health | 12 Hour Sinus Relief Nasal Mist | Product was found to contain Pseudomonas aeruginosa | Product Quest Manufacturing (“Product Quest”) | ||
| 08/08/2018 | Camber Pharmaceuticals, Inc. | Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg | Detection of trace amounts of N-Nitrosodimethylamine (NDMA) | Camber Pharmaceuticals, Inc. | ||
| 07/31/2018 | Auromedics | Piperacillin and Tazobactam for injection, USP 3.375 g | Glass and silicone particulate matter | AuroMedics Pharma | ||
| 07/28/2018 | Ranier's RX Laboratory | Compounded drug products | Sterility concerns | Ranier's RX Laboratory | ||
| 07/20/2018 | Dr. King’s, Dr. King’s Aquaflora | Homeopathic liquids: Candida liquid, lymph detox liquid, baby teething liquid | microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans. | King Bio Inc. | ||
| 07/17/2018 | Actavis | Valsartan and Valsartan Hydrochlorothiazide Tablets | Impurity detected in the API is Nnitrosodimethylamine (NDMA) | Teva Pharmaceuticals USA | ||
| 07/17/2018 | Prinston Pharmaceutical Inc. dba Solco Healthcare LLC | Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg | Detection of a Trace Amount of Unexpected Impurity, N- nitrosodimethylamine (NDMA) | Prinston Pharmaceutical Inc. dba Solco Healthcare LLC | ||
| 07/13/2018 | Major Pharmaceuticals | Valsartan tablets, 80mg USP and 160 mg USP | may contain the probable carcinogen Nnitrosodimethylamine (NDMA) | Major Pharmaceuticals | ||
| 06/30/2018 | Kratom Powder Capsule | Kratom Powder Capsule | Potential Salmonella Contamination | Blissful Remedies | ||
| 06/29/2018 | Fagron Sterile Services | Neostigmine Methylsulfate 5 mL Syringes | Mislabeling | Fagron Sterile Services | ||
| 06/28/2018 | Hospira | Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial | Causes Infusion Reactions | Hospira Inc. | ||
| 06/21/2018 | Gaia Ethnobotanical | Kratom Products | Potential Salmonella contamination | Gaia Ethnobotanical, LLC | ||
| 06/04/2018 | Hospira | Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use cartridge Syringe System | Potential Presence of Particulate Matter | Hospira Inc. | ||
| 05/31/2018 | Apotex | Fluticasone Propionate Nasal Spray | Potential for small glass particles | Apotex Corp. | ||
| 05/29/2018 | Taytulla | Birth control capsules | Out of order packaging | Allergan | ||
| 05/25/2018 | X-Jow, Acne Shave | Pain Gel, Moisturizer, Shave Cream | Products may be contaminated with bacteria | Shadow Holdings | ||
| 05/18/2018 | MBI Distributing, Inc. | Various Homeopathic Products | Lack of adequate manufacturing controls | MBI Distributing, Inc. | ||
| 05/17/2018 | 7K and Poseidon | 7K and Poseidon 4500 Dietary Supplements | Undeclared Sildenafil and Tadalafil | Shoreside Enterprises | ||
| 05/14/2018 | Apotex Corporation | Piperacillin and Tazobactam for Injection | Elevated level of impurities | Apotex Corporation | ||
| 05/14/2018 | AuroMedics Pharma LLC | Piperacillin and Tazobactam for injection, USP 3.375 g/vial | Presence of glass particulates | AuroMedics Pharma LLC | ||
| 05/04/2018 | HeartMate 3 | Left Ventricular Assist Device | Outflow graft twisting could occur post-implant | Abbott | ||
| 05/03/2018 | AuroMedics Pharma LLC | Ampicillin and Sulbactam for Injection USP, 3 grams/ Single-Dose vial | Presence of visible particulate matter | AuroMedics Pharma LLC | ||
| 04/12/2018 | AMA Wholesale Inc. | Rhino 69 Extreme 50000 capsules | Unapproved New Drug (Presence of Tadalafil) | AMA Wholesale Inc. | ||
| 04/11/2018 | Premier Pharmacy Labs | Sterile Injectable Drug Products | Potential lack of sterility assurance | Premier Pharmacy Labs | ||
| 03/29/2018 | PASTA DE LASSAR ANDROMACO | Pasta De Lassar Andromaco Skin Protectant | Potential for contamination with yeast, mold, and bacteria | MarcasUSA, LLC | ||
| 03/29/2018 | PASTA DE LASSAR ANDROMACO | Pasta De Lassar Andromaco Skin Protectant | Potential for contamination with yeast, mold, and bacteria | MarcasUSA, LLC | ||
| 03/22/2018 | BD | Vacutainer tubes | Concerns about inaccurate lead test results and updating instruction for use | BD | ||
| 03/15/2018 | Bayer | Alka-Seltzer Plus | Labeling Error | Bayer | ||
| 03/05/2018 | Hospira, Inc. | Hydromorphone HCL Injection, USP | Units may be empty or cracked at the bottom of the glass vial | Hospira, Inc. | ||
| 03/05/2018 | Sagent | Methylprednisolone Sodium Succinate for Injection, USP 40mg, 125mg, and 1g | Out of Specification Impurity Results | Sagent Pharmaceuticals | ||
| 02/23/2018 | Hospira, Novaplus | Labetalol Hydrochloride Injection, USP | Cracked Glass At The Rim Surface Of The Vials | Hospira, Inc. | ||
| 02/15/2018 | AVpak | Acyclovir Tablet, USP, 400mg, 50ct Unit Dose | Product mix-up | Apace Packaging LLC | ||
| 01/29/2018 | Gericare | Sterile Eye Irrigation Solution | Potential microbial contamination which compromises sterility | Kareway Products Inc. | ||
| 01/26/2018 | Limbrel | Limbrel, Limbrel 250, Limbrel 500 | Due to potential serious side effects | Primus Pharmaceuticals, Inc. | ||
| 01/19/2018 | Basic Drugs | Senna Laxative | Mislabeling | Magno-Humphries Laboratories, Inc. | ||
| 01/16/2018 | Nexterone | Nexterone 150mg/100ml injection | Presence of particulate matter | Baxter International Inc. | ||
| 01/12/2018 | AuroMedics | Levofloxacin in 5% Dextrose Injection 250mg/50mL | Particulate Matter | AuroMedics Pharma LLC | ||
| 01/11/2018 | PharMEDium Services LLC | Various compounded drug products intended to be sterile | Lack of sterility assurance | PharMEDium Services LLC | ||
| 01/10/2018 | International Laboratories, LLC | Clopidogrel Tablets USP, 75 mg | Due to mis-labeling | International Laboratories, LLC | ||
| 01/09/2018 | AuroMedics Pharma LLC | Ampicillin and Sulbactam for Injection USP | Presence of glass particles | AuroMedics Pharma LLC | ||
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