Drugs

Drug Recalls

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. See Definitions of Market Withdrawals and Class I, II, and III recalls. All recalls (Class I, II, and III) can be found in the FDA Enforcement Report

In July 2011, FDA began a pilot program to notify people of drug recalls before they are classified. These unclassified recalls will be published in the Enforcement Report every Wednesday, and will be listed under the heading, “Human Drug Product Recalls Pending Classification.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.

If you have a medicine that has been recalled, talk to your health care professional about the best course of action.  Stores generally have a return and refund policy when a company has announced a recall of its products.

NOTE:  The recalls on the list are generally Class I., which means there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

 

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Date Brand Name Product Description Reason/ Problem Company Recall Type
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
05/03/2018 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
07/13/2017 New of Kopi Jantan Tradisional   Natural Herbs Coffee Dietary Supplement   Unapproved new drug, Undeclared Milk Allergen Bestherbs Coffee LLC 454, 208, 220, 69, 76
07/11/2017 Andropharm   Sten Z and M1 Alphas capsules   Unapproved drug Andropharm 208, 202, 512
06/29/2017 Ultra-Sten, D-Zine   Marketed as a dietary supplement   Presence of anabolic steroids Hardcore Formulations 202, 208
06/23/2017 Fagron Sterile Services   Succinylcholine Chloride 20mg/mL   Lack of Sterility Assurance Fagron Sterile Services 208
06/22/2017 Advanced Pharma   Potassium Phosphate and Succinylcholine Chloride   Lack of Sterility Assurance Advanced Pharma, Inc. d/b/a Avella of Houston 91, 208
06/17/2017 Bristol-Myers Squibb   Eliquis (apixaban) 5 mg Tablets   Tablet Mix-Up Bristol-Myers Squibb 454, 208
06/16/2017 Alvogen   Clindamycin Injection USP   Lack of sterility assurance Alvogen 454, 208
06/15/2017 Hospira   8.4% Sodium Bicarbonate Injection, USP, NeutTM (Sodium Bicarbonate 4% additive solution), QUELICINTM (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP   Lack of Sterility Assurance Hospira Inc, A Pfizer Company 208
06/15/2017 Advanced Pharma   Nitroglycerin products   Due to sub-potency Advanced Pharma, Inc. d/b/a Avella of Houston 208
06/15/2017 Teva Pharmaceuticals USA, Inc   Paliperidone Extended-Release Tablets, 3mg   Potential for product to be below specification Teva Pharmaceuticals USA, Inc 454, 208
06/10/2017 Bristol-Myers Squibb   Eliquis (apixaban) 5 mg Tablets   Tablet Mix-Up Bristol-Myers Squibb 91, 208
06/09/2017 Tetracycline-ABC, Tetrastem, Diabecline and more   topical products   Concerns of Manufacturing Practices Phillips Company 454, 208
05/25/2017 Caverflo   Natural Herbal Coffee   Undeclared Sildenafil and Tadalafil, Undeclared Milk Caverflo.com 454, 220, 208, 69, 76
05/25/2017 Lupin   Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg)   Out of Sequence Tablets and Missing Expiry/Lot information Lupin Pharmaceuticals Inc. 454, 208
05/25/2017 Astrazeneca   professional (physician) sample BRILINTA (ticagrelor) 90mg tablets   Product container contained another medicine called ZURAMPIC Astrazeneca 454, 208

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Page Last Updated: 05/18/2018
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