Drugs

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.

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Date Brand Name Product Description Reason/ Problem Company Recall Type
12/05/2018 Family Wellness, CVS, Equate   Infants’ Ibuprofen   Products may have higher concentrations of Ibuprofen Tris Pharma 208, 91
12/04/2018 Mylan   Valsartan-containing products   Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient Mylan Pharmaceuticals 208
11/27/2018 Teva Pharmaceuticals   Amlodipine/Valsartan Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination Tablets   Impurity N-nitroso-diethylamine (NDEA) in API Teva Pharmaceuticals 208
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 454, 208
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 208
11/12/2018 Oscor   Temporary Bipolar Pacing Lead, Model TB   Connector cap housing may slide and potentially expose the connection wire. Oscor Inc. 208
11/08/2018 Losartan   Losartan Potassium Hydrochlorothiazide   Product contains NDEA impurity Sandoz Inc 208, 91
11/07/2018 Puriton   Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle   Non-Sterile Production Conditions Kadesh Inc. 208, 91
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. 454, 208
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 208
10/26/2018 Aurobindo Pharma Limited   Irbesartan Drug   Due to the presence of an impurity, N-nitrosodiethylamine (NDEA) Aurobindo Pharma Limited 208, 91
10/22/2018 Promise Pharmacy   Prednisolone and Gatifloxacin Ophthalmic Solution   Unidentified small particulate floating in the solution Promise Pharmacy 208
10/15/2018 Zero Xtreme   Dietary Supplement for Weight Loss   Undeclared Sibutramine Fat Burners Zone 454, 208
10/10/2018 ReGen Series   All ReGen Series products   Adverse reactions Liveyon, LLC 208
10/09/2018 Sprayology   Homeopathic Aqueous-Based Medicines   Possible microbial contamination Eight and Company LLC, dba Sprayology 208
10/03/2018 Pet Alive, Native Remedies, Healthful Naturals   Homeopathic Drug Products (liquid)   Microbial Contamination Silver Star Brands, Inc. 208, 183, 495
09/28/2018 Endo Pharmaceuticals   Robaxin® (methocarbamol tablets, USP) 750mg Tablets   Due to Incorrect Daily Dosing Information on Label Endo Pharmaceuticals 208
09/12/2018 NeoRelief   Muscle   Due to possible microbial contamination BioLyte Laboratories 208
09/10/2018 Pharm D Solutions   Compounded drugs   Lack of Sterility Assurance Pharm D Solutions LLC 208
09/06/2018 SCA Pharmaceuticals   Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag   visible particulate matter SCA Pharmaceuticals LLC (“SCA Pharma”) 208
09/05/2018 Beaumont Bio Med Homeopathic   Homeopathic oral sprays   Microbial contamination Beaumont Bio Med, Inc. 208
09/05/2018 Camber Pharmaceuticals   Montelukast Sodium Tablets, USP 10mg   Product label mix up/may contain Losartan Potassium Tablets Camber Pharmaceuticals, Inc 208
08/29/2018 Neuroveen, Respitrol, Thyroveev, Compulsin   Homeopathic Medicines   Possible Microbial Contamination HelloLife, Inc. 208
08/29/2018 CyPass   Micro-Stent   Significant endothelial cell loss Alcon 208
08/28/2018 CVS, Rhinall, Humist, more   Nasal Products and Baby Oral Gels   Pseudomonas aeruginosa contamination Product Quest Manufacturing LLC 454, 208
08/27/2018 Accord   Hydrochlorothiazide Tablets USP 12.5 mg   Labeling mix-up/may contain Spironolactone Tablets Accord Healthcare Inc. 454, 208
08/27/2018 Children’s Advil   Ibuprofen Oral Suspension   Dosage cup has incorrect measurement markings Pfizer, Inc. 208
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 208
08/22/2018 KB, DK, more   Homeopathic products   Microbial contamination King Bio 208
08/17/2018 Torrent   Valsartan/Amlodipine/HCTZ Tablets   Impurity detected in the API is N-nitrosodimethylamine (NDMA) Torrent Pharmaceuticals 454, 208
08/13/2018 Blissful Remedies   Products Containing Kratom   High microbial load World Organix, LLC 208
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 208
08/08/2018 CVS Health   12 Hour Sinus Relief Nasal Mist   Product was found to contain Pseudomonas aeruginosa Product Quest Manufacturing (“Product Quest”) 208
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. 208
07/31/2018 Auromedics   Piperacillin and Tazobactam for injection, USP 3.375 g   Glass and silicone particulate matter AuroMedics Pharma 208, 91
07/28/2018 Ranier's RX Laboratory   Compounded drug products   Sterility concerns Ranier's RX Laboratory 208
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. 91, 208
07/17/2018 Actavis   Valsartan and Valsartan Hydrochlorothiazide Tablets   Impurity detected in the API is Nnitrosodimethylamine (NDMA) Teva Pharmaceuticals USA 208
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 208
07/13/2018 Major Pharmaceuticals   Valsartan tablets, 80mg USP and 160 mg USP   may contain the probable carcinogen Nnitrosodimethylamine (NDMA) Major Pharmaceuticals 208
06/30/2018 Kratom Powder Capsule   Kratom Powder Capsule   Potential Salmonella Contamination Blissful Remedies 208
06/29/2018 Fagron Sterile Services   Neostigmine Methylsulfate 5 mL Syringes   Mislabeling Fagron Sterile Services 208
06/28/2018 Hospira   Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial   Causes Infusion Reactions Hospira Inc. 454, 208
06/21/2018 Gaia Ethnobotanical   Kratom Products   Potential Salmonella contamination Gaia Ethnobotanical, LLC 208
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. 208, 91
05/31/2018 Apotex   Fluticasone Propionate Nasal Spray   Potential for small glass particles Apotex Corp. 91, 208
05/29/2018 Taytulla   Birth control capsules   Out of order packaging Allergan 91, 208
05/25/2018 X-Jow, Acne Shave   Pain Gel, Moisturizer, Shave Cream   Products may be contaminated with bacteria Shadow Holdings 454, 208
05/18/2018 MBI Distributing, Inc.   Various Homeopathic Products   Lack of adequate manufacturing controls MBI Distributing, Inc. 208
05/17/2018 7K and Poseidon   7K and Poseidon 4500 Dietary Supplements   Undeclared Sildenafil and Tadalafil Shoreside Enterprises 54, 512, 208
05/14/2018 Apotex Corporation   Piperacillin and Tazobactam for Injection   Elevated level of impurities Apotex Corporation 208
05/14/2018 AuroMedics Pharma LLC   Piperacillin and Tazobactam for injection, USP 3.375 g/vial   Presence of glass particulates AuroMedics Pharma LLC 208
05/04/2018 HeartMate 3   Left Ventricular Assist Device   Outflow graft twisting could occur post-implant Abbott 208
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 208
04/12/2018 AMA Wholesale Inc.   Rhino 69 Extreme 50000 capsules   Unapproved New Drug (Presence of Tadalafil) AMA Wholesale Inc. 91, 208, 202, 512
04/11/2018 Premier Pharmacy Labs   Sterile Injectable Drug Products   Potential lack of sterility assurance Premier Pharmacy Labs 454, 208
03/29/2018 PASTA DE LASSAR ANDROMACO   Pasta De Lassar Andromaco Skin Protectant   Potential for contamination with yeast, mold, and bacteria MarcasUSA, LLC 208
03/29/2018 PASTA DE LASSAR ANDROMACO   Pasta De Lassar Andromaco Skin Protectant   Potential for contamination with yeast, mold, and bacteria MarcasUSA, LLC 208
03/22/2018 BD   Vacutainer tubes   Concerns about inaccurate lead test results and updating instruction for use BD 208
03/15/2018 Bayer   Alka-Seltzer Plus   Labeling Error Bayer 208
03/05/2018 Hospira, Inc.   Hydromorphone HCL Injection, USP   Units may be empty or cracked at the bottom of the glass vial Hospira, Inc. 208
03/05/2018 Sagent   Methylprednisolone Sodium Succinate for Injection, USP 40mg, 125mg, and 1g   Out of Specification Impurity Results Sagent Pharmaceuticals 454, 208
02/23/2018 Hospira, Novaplus   Labetalol Hydrochloride Injection, USP   Cracked Glass At The Rim Surface Of The Vials Hospira, Inc. 454, 208
02/15/2018 AVpak   Acyclovir Tablet, USP, 400mg, 50ct Unit Dose   Product mix-up Apace Packaging LLC 454, 208
01/29/2018 Gericare   Sterile Eye Irrigation Solution   Potential microbial contamination which compromises sterility Kareway Products Inc. 208
01/26/2018 Limbrel   Limbrel, Limbrel 250, Limbrel 500   Due to potential serious side effects Primus Pharmaceuticals, Inc. 454, 208
01/19/2018 Basic Drugs   Senna Laxative   Mislabeling Magno-Humphries Laboratories, Inc. 454, 208
01/16/2018 Nexterone   Nexterone 150mg/100ml injection   Presence of particulate matter Baxter International Inc. 454, 208
01/12/2018 AuroMedics   Levofloxacin in 5% Dextrose Injection 250mg/50mL   Particulate Matter AuroMedics Pharma LLC 208
01/11/2018 PharMEDium Services LLC   Various compounded drug products intended to be sterile   Lack of sterility assurance PharMEDium Services LLC 208
01/10/2018 International Laboratories, LLC   Clopidogrel Tablets USP, 75 mg   Due to mis-labeling International Laboratories, LLC 454, 208
01/09/2018 AuroMedics Pharma LLC   Ampicillin and Sulbactam for Injection USP   Presence of glass particles AuroMedics Pharma LLC 454, 208
12/27/2017 PharMEDium Services, LLC   Compounded injectables   Lack of Sterility Assurance PharMEDium Services, LLC 91, 208
12/22/2017 AuroMedics   Linezolid Injection   Particulate contamination (mold) AuroMedics Pharma 454, 208
12/19/2017 AuroMedics Pharma LLC   Pantoprazole Sodium for Injection 40 mg per vial   Contains glass particles AuroMedics Pharma LLC 208

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Page Last Updated: 12/12/2018
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