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
05/17/2016 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
09/25/2015 RHINO 7   Capsules intended for male sexual enhancement   Undeclared desmethyl carbondenafil and dapoxetine TF Supplements 454, 208
09/23/2015 Lucy's Weight Loss System   Pink Bikini and Shorts on The Beach   Undeclared Sibutramine and Phenolphthalein Lucy's Weight Loss System 454, 208
09/21/2015 US Compounding, Inc.   All sterile compounded products   Lack of sterility assurance US Compounding, Inc. 454, 208
09/11/2015 The One Minute Miracle Inc.   Miracle 30 & Miracle Rock 48 dietary supplements   Unapproved new drug The One Minute Miracle Inc. 454, 512, 54, 208
09/09/2015 Medistat RX, LLC   Sterile Drug Products   Sterility cannot be assured Medistat RX, LLC 454, 208
08/24/2015 Fataway Ultimate Stack, ThermoFX, MaxOut Body, Metabolic Accelerator, Burn Fat Now, Thermogenic Fat Burner, Thin and Slim Naturally, Extreme Stack, Asia Black, Black Widow 25, and Methyldrene Original 25   Dietary Supplements   These products contain the undeclared drug ingredient salicylic acid making these unapproved new drugs Novacare, LLC 454, 208
08/24/2015 REFRESH®, FML® and Blephamide®   REFRESH® Lacri-Lube®, REFRESH P.M.®, FML® (fluorometholone ophthalmic ointment) and Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP)   Contains particulate matter Allergan plc 454, 208
08/17/2015 Hartley Medical   Prolotherapy with Phenol   Non-sterility concerns Hartley Medical 454, 208
08/07/2015 Moses Lake Professional Pharmacy   Human and veterinary sterile compounded drugs   Sterility Assurance Moses Lake Professional Pharmacy 454, 69, 220, 183, 495, 184, 208
07/31/2015 Baxter   0.9 % Sodium Chloride Injection, USP (AUTO-C)   Leaking containers, particulate matter and missing port protectors Baxter International Inc. 454, 208
07/24/2015 Teva Parenteral Medicines Inc.   Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL)   Potential presence of particulate matter Teva Parenteral Medicines Inc. 454, 208
07/23/2015 Akttive   High Performance Fat Burner Gold capsules   Undeclared Drug Ingredients Life & More, LLC 454, 208
07/17/2015 Baxter   0.9 % Sodium Chloride Injection, USP; 50mL and 100 mL   Presence of particulate matter Baxter International Inc. 454, 208
07/13/2015 Mylan Institutional LLC   Calcium Chloride Intravenous Infusion 10% in 10 mL prefilled glass syringes   Incompatibility between syringe and needleless adapters Mylan Institutional LLC 208, 182
06/12/2015 Pyrola   Advanced Joint Formula capsules   undeclared diclofenac and chlorpheniramine G&C Natural 454, 208
06/08/2015 Mylan   Gemcitabine, Methotrexate   Particulate Matter Mylan 208
06/03/2015 Smart Lipo   Smart Lipo (800, 900, 950 mg) capsules   Undeclared sibutramine, desmethylsibutramine, and phenolphthalein. SmartLipo365 454, 512, 54, 208

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Page Last Updated: 05/26/2016
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