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
09/20/2016 Wells Pharmacy Network   Sterile human and veterinary compounded products   Concern for Lack of Sterility Assurance Wells Pharmacy Network 208, 495, 183
09/14/2016 Virtus   Hyoscyamine Sulfate 0.125 mg tablets   Superpotent and subpotent test results Virtus Pharmaceuticals Opco II, LLC 208
09/08/2016 GlucaGen® HypoKit®   Glucagon [rDNA origin] for injection   Detached needles on the syringe in the kit Novo Nordisk Inc. 36, 208
09/07/2016 Family Care   Eye Wash   Microbial contamination United Exchange Corp 454, 208
09/06/2016 Rugby, Major   Eye irrigating solution and Eye wash   Possible microbial contamination United Exchange Corp. 36, 208
08/26/2016 Lamotrigine   Lamotrigine   Incorrect labeling of blister cards Impax Laboratories, Inc. 208, 36
08/19/2016 Comfort   Comfort Shield Barrier Cream Cloths   Burkholderia cepacia Sage Products 36, 208
08/18/2016 Sagent Pharmaceuticals, Inc.   Oxacillin for Injection, USP, 10 g   May contain small, dark particulate matter (iron oxide) Sagent Pharmaceuticals, Inc. 454, 208
08/18/2016 Arbor   Cetylev (acetylcysteine) effervescent tablets   Inadequate seal of the blister pack Arbor Pharmaceuticals, LLC 454, 208
08/12/2016 Comfort   Comfort Shield Barrier Cream Cloths   Burkholderia cepacia Sage Products 208, 36
08/08/2016 Multiple brands   Liquid Drug Products   Due to potential Burkholderia cepacia contamination PharmaTech, LLC 454, 208
08/05/2016 Hospira   0.25% BUPIVACAINE HYDROCHLORIDE INJECTION, USP   Due to the presence of particulate matter Hospira 208, 36
08/02/2016 Teva Pharmaceuticals   Amikacin Sulfate Injection USP   Due to potential contamination with glass particulate matter Teva Pharmaceuticals 208
08/01/2016 Comfort Shield   Barrier Cream Cloths   Due to product contamination with Burkholderia cepacia Sage Products 208, 509
07/21/2016 Talon Compounding Pharmacy (TCP)   HCG and Sermorelin   Lack of sterility assurance Talon Compounding Pharmacy (TCP) 208
07/15/2016 Rugby   Diocto Liquid, docusate sodium solution   Burkholderia cepacia contamination PharmaTech LLC 208
05/17/2016 Well Care Compounding Pharmacy   Unexpired sterile compounded products   Concern over lack of sterility assurance Well Care Compounding Pharmacy 208, 105, 104, 183, 184, 495
05/10/2016 Tiger-X, Ninja-X, Ginseng Power-X, Super Samurai-X   Marketed as a dietary supplement   Products contain Sildenafil, and analogs of Sildenafil SOS Telecom, Inc. 54, 512, 208
05/05/2016 PharMEDium   Sterile Preparations Compounded With Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl)   Presence of glass particulate PharMEDium Services LLC 454, 208
04/19/2016 Pharmakon Pharmaceuticals, Inc.   Sterile compounded products   Lack of sterility assurance Pharmakon Pharmaceuticals, Inc. 208
04/13/2016 Hospira   50% Magnesium Sulfate Injection, USP   Particulate Matter Hospira, Inc. 454, 208
04/11/2016 Super Herbs   Super Herbs Capsules, Weight Loss Dietary Supplement   Unapproved new drug- FDA laboratory testing found SUPER HERBS to contain sibutramine, desmethylsibutramine, and/or phenolphthalein. Super Herbs 454, 208, 512, 54
04/05/2016 Continuum Labs   Marketed as a dietary supplement   Contains Ligandrol INVISIBLU International LLC 454, 208, 512, 54
03/28/2016 B. Braun Medical Inc.   5% Dextrose Injection USP   Leakage and visible particulate matter (microbial growth) B. Braun Medical Inc. 454, 208
03/18/2016 Hospira   8.4% Sodium Bicarbonate Injection, USP   Presence of particulate matter Hospira Inc. 454, 208
03/09/2016 Teva Pharmaceuticals   Amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL)   Due to the potential presence of particulate matter identified as glass in one vial Teva Pharmaceuticals 454, 208
03/01/2016 Sagent Pharmaceuticals, Inc.   Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100mL   Discovery of an out of specification impurity result detected Sagent Pharmaceuticals, Inc. 454, 208
02/17/2016 Baxter   0.9% Sodium Chloride Solution   Particulate Matter Baxter International Inc. 454, 208
02/16/2016 Pharmakon Pharmaceuticals   morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride   Super-potent Pharmakon Pharmaceuticals 454, 208
01/28/2016 Lucy's Weight Loss System   Pink Bikini and Shorts on The Beach   Undeclared Sibutramine, Phenolphthalein, and/or Diclofenac Lucy's Weight Loss System 454, 208
01/26/2016 Baxter   0.9% Sodium Chloride Injection, Metronidazole Injection, and Clinimix E 5/15   Leaking containers and particulate matter Baxter International Inc. 208
01/20/2016 Master Herbs, Inc.   Licorice Coughing Liquid   Contains undeclared morphine Master Herbs, Inc. 454, 208
01/16/2016 Abbott's Compounding Pharmacy   Sterile Compounded Products that include injectable medications, sterile solutions, eye drops, and eye ointments   Lack of Sterility Assurance Abbott's Compounding Pharmacy 454, 208, 495, 183
01/09/2016 R Thomas Marketing LLC   Dietary Supplement   Unapproved new drug R Thomas Marketing LLC 454, 54, 512, 208
12/31/2015 PharMEDium   Norepinephrine Bitartrate added to Sodium Chloride   Discoloration PharMEDium Services, LLC 208
12/23/2015 La' Trim Plus, Jenesis and Oasis   Dietary Supplement   Undeclared Sibutramine and Phenolphthalein BeeXtreme LLC 512, 54, 208
12/18/2015 SmartLipo365   Dietary Supplement   Unapproved new drug SmartLipo365 454, 512, 54, 208
12/18/2015 Baxter   intravenous (IV) solutions: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container and 70% Dextrose Injection (2000 mL) USP   Potential presence of particulate matter. Baxter International Inc. 208
12/11/2015 Fuel Up   Dietary Supplement   Unapproved new drug (undeclared hydroxythiohomosildenafil, an analogue of sildenafil) Reesna Inc., 454, 512, 592, 208
12/09/2015 Pink Bikini   Dietary Supplement   Unapproved new drug (Undeclared diclofenac) Lucy's Weight Loss System 454, 512, 208, 54
12/03/2015 Lipo Escultura   Dietary Supplement   Unapproved new drug Lipo Escultura 454, 208, 512, 54
11/25/2015 Glades Drugs   Compounded Multivitamins   Contains high amounts of Vitamin D3 Glades Drugs 454, 208
10/30/2015 Auvi-Q   Epinephrine injection, USP (0.15 mg and 0.3 mg)   Potential Inaccurate Dosage Delivery Sanofi US 454, 208
10/28/2015 Rhino 7   Dietary Supplement   Undeclared Active Pharmaceutical Ingredients Premiere Sales Group 454, 208, 512, 54
10/20/2015 Downing Labs, LLC   All sterile compounded products   Lack of sterility assurance *Company Name Downing Labs, LLC 208
10/09/2015 Medline Industries, Inc.   Over the counter Acetaminophen tablets.   The Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets. Medline Industries, Inc. 454, 208

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Page Last Updated: 09/24/2016
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