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
02/24/2017 Edex   Alprostadil for injection   Potential Lack of Sterility Assurance Endo Pharmaceuticals Inc. 454, 208, 220
02/23/2017 Advanced Pharma   All unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location   Products may contain synthetic latex and/or natural latex Avella Specialty Pharmacy 454, 208
02/17/2017 Synergy Rx Pharmacy   Non-sterile drug products   Lack of Quality Assurance Synergy Rx Pharmacy 454, 208, 220
02/14/2017 Synergy Rx Pharmacy   Human Chorionic Gonadotropin (HCG) for injection   Lack of Sterility Assurance Synergy Rx Pharmacy 454, 208
02/08/2017 X-Gen   Ibuprofen Lysine Injection, 20 mg/2 mL   Presence of particulate matter Exela Pharma Sciences, LLC 208
01/24/2017 Hospira, Inc.   Vancomycin Hydrochloride for injection   Particulate matter Hospira, Inc. 454, 208
12/28/2016 Duravet   Duramycin-10 Soluble Powder   Stability Failure Huvepharma, Inc 208, 183
11/29/2016 Megajex   Male Sex Enhancer Dietary Supplement   Unapproved new drug MS Bionic, Inc 208, 512, 54, 42
11/24/2016 CVS and Kids Relief   Homeopathic products   Misdeclared Belladonna extract levels Raritan Pharmaceuticals 454, 208, 220
11/18/2016 Tri-Coast Pharmacy Inc.   Sterile drug products   Concern for lack of sterility assurance Tri-Coast Pharmacy Inc. 208, 36, 42
11/18/2016 Cantrell Drug Company   Sterile drug products   Concern for Lack of Sterility Assurance Cantrell Drug Company 208, 36, 42
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


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Page Last Updated: 03/23/2017
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