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
09/06/2017 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
05/08/2017 Truxton Incorporated   Amitriptyline HCL Tablets, USP 50mg and Phenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg   Labeling mix-up C.O. Truxton, Inc. 208, 184, 495, 188, 105, 183, 104
05/05/2017 GEC Laxoplex   Marketed as a dietary supplement   Presence of anabolic steroids Genetic Edge Compounds 454, 208, 54, 512
04/21/2017 Hospira, Inc.   25% Dextrose Injection, USP (Infant)   Particulate matter (human hair) Hospira, Inc. 208
04/21/2017 C.O. Truxton, Inc.   Phenobarbital Tablets, USP, 15 mg   Product may contain 30 mg tablets C.O. Truxton, Inc. 208, 183, 495
04/18/2017 Uproar, Cummor, Zrect, Monkey Business and others   Dietary Supplement   Unapproved new drug Organic Herbal Supply, Inc. 454, 208, 512, 54
04/13/2017 Hyland's   Baby teething tablets and Nightime teething tablets   Contains inconsistent amounts of belladonna alkaloids Standard Homeopathic Company 454, 208
04/06/2017 Isomeric Pharmacy Solutions   Multiple compounded sterile products   Concerns of lack of sterility assurance Isomeric Pharmacy Solutions 208
03/31/2017 Mylan   EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors   Failure to activate the device due to a potential defect Mylan N.V. 454, 208
03/28/2017 LaBri’s Body Health   Dietary Supplement   Unapproved new drug Envy Me 454, 208, 512, 592
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 Cantrell Drug Company   Sterile drug products   Concern for Lack of Sterility Assurance Cantrell Drug Company 208, 36, 42
11/18/2016 Tri-Coast Pharmacy Inc.   Sterile drug products   Concern for lack of sterility assurance Tri-Coast Pharmacy Inc. 208, 36, 42

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Page Last Updated: 09/20/2017
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