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
07/13/2018 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
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
11/30/2017 Pharmacist Choice   Alcohol Prep Pads   Lack of sterility assurance Simple Diagnostics 454, 208
11/24/2017 Sun Pharma   Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL   Microbial Contamination (Scopulariopsis brevicaulis) Sun Pharmaceutical Industries Ltd 454, 208
11/16/2017 Greenstone LLC   diphenoxylate hydrochloride and atropine sulfate tablets, USP   Sub Potent and Super Potent Tablets Greenstone LLC, a wholly owned subsidiary of Pfizer Inc. 208
11/14/2017 Nexterone   Amiodarone HCl   Particulate matter Baxter International Inc 454, 208
11/03/2017 Fresenius Kabi USA   Midazolam Injection, USP prefilled syringe   Mislabeled Fresenius Kabi USA 454, 208
11/01/2017 Ridge Properties DBA Pain Relief Naturally   Pain and itch relief products   Violations of current good manufacturing practice regulations. Ridge Properties DBA Pain Relief Naturally 454, 208
10/20/2017 SCA Pharmaceuticals LLC   Injectable drugs   Lack of Sterility Assurance SCA Pharmaceuticals LLC 454, 208
10/05/2017 Baxter   INTRALIPID 20% IV Fat Emulsion, 100 mL   Product exposed to subfreezing temperatures Baxter International Inc. 454, 208
10/05/2017 A1 Slim   Dietary Supplement A1 Slim   Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine Kiriko, LLC 91, 95, 208
09/06/2017 Genentech   Activase® (alteplase) 100mg vials   Lack of Sterility Assurance of the Sterile Water for Injection Genentech 454, 208
09/01/2017 PharMEDium   Oxytocin   Sub-potency PharMEDium Services, LLC 454, 208
08/31/2017 HYDROmorphone, Levophed   Hydromorphone HCl, Levophed   Lack of Sterility Assurance Hospira, Inc. 454, 208
08/30/2017 Hospira, Inc.   Vancomycin Hydrochloride for Injection   Particulate Matter Hospira, Inc. 454, 208
08/30/2017 Doctor Manzanilla   Allergy, cough medicine   Burkholderia cepacia Mid Valley Pharmaceutical 208
08/30/2017 Piyanping   Anti-Itch Lotion   Contains dexamethasone instead of hydrocortisone Lucky Mart Inc. 208
08/22/2017 Centurion   Ninjacof and Ninjacof A   Potential contamination with Burkholderia cepacia Centurion Labs 454, 208, 220
08/18/2017 Bella Pharma   All lots of unexpired sterile drug products   Due to lack of sterility assurance Bella Pharmaceuticals, Inc. 454, 208
08/17/2017 Atlantic Pharmacy and Compounding   All compounded injectable prescription medications   Due to lack of sterility assurance Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding 454, 208
08/14/2017 Amneal Pharmaceuticals LLC   Lorazepam Oral Concentrate, USP 2mg/mL   Misprinted Dosing Droppers Amneal Pharmaceuticals LLC 454, 208
08/10/2017 Leader, Major, Rugby   Liquid drug products   Potential contamination with B. cepacia Cardinal Health 208
08/09/2017 International Laboratories, LLC   Pravastatin Sodium Tablets   Labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets International Laboratories, LLC 91, 208
08/04/2017 Man of Steel   Man of Steel 1 and Man of Steel 2   Contains Undeclared Sildenafil Man of Steel 454, 208
08/02/2017 Rugby   Diocto Liquid and Diocto Syrup   Potential contamination with Burkholderia cepacia Rugby® Laboratories 454, 208
07/28/2017 ICU Medical, Inc.   0.9% Sodium Chloride Injection, USP 1000 mL   Particulate matter ICU Medical, Inc. 91, 208
07/27/2017 Apace Packaging LLC   Cyclobenzaprine HCl Tablet and Amantadine HCl Capsule   Cyclobenzaprine HCL may contain Amantadine HCL Capsules Apace Packaging LLC 454, 208
07/25/2017 Cantrell Drug Company   All unexpired sterile drug syringes and IV bags   Lack of sterility assurance Cantrell Drug Company 208
07/21/2017 Super Panther 7K   Dietary Supplement   Unapproved new drug Ultra Shop Supplement 202, 208, 512, 91

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Page Last Updated: 07/13/2018
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