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
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 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
08/24/2015 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
08/17/2015 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
05/04/2015 Adrucil   Adrucil (fluorouracil injection, USP) 5g/100mL   Particulate matter Teva Parenteral Medicines 454, 208
04/23/2015 Hospira, Inc.   Preservative-Free Bupivacaine HCl Injection, USP   Iron oxide particles Hospira, Inc. 454, 208, 105, 495, 104, 183, 495
04/23/2015 Mylan   Gemcitabine, Carboplatin, Methotrexate, and Cytarabine   Presence of particulate matter Mylan Pharmaceuticals Inc. 454, 208
04/22/2015 Mucinex Fast-Max   Mucinex Fast-Max   Incorrect labeling - Undeclared levels of Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or Diphenhydramine RB (formerly Reckitt Benckiser) 208
04/10/2015 Baxter   Sodium Chloride, Dextrose, and Lactated Ringer's Injections   Particulate Matter Baxter International Inc. 454, 208
04/01/2015 Prescription Center Pharmacy   All lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy between September 10, 2014, and March 10, 2015   Pharmacy’s inability to ensure sterility, stability, and potency for these products. Prescription Center Pharmacy 454, 208, 183, 495
03/11/2015 Hospira   Lactated Ringer's Irrigation, 3000mL   Due to mold contamination Hospira, Inc 454, 208
03/10/2015 UltraZx   UltraZx weight loss supplements, packaged bottles of 30 capsules, 300mg   Contains undelcared Sibutramine and phenolphthalein Ultra ZX Labs, LLC 454, 208
03/06/2015 Hospira   Magnesium Sulfate in 5% Dextrose, Inj   Incorrect barcode Hospira, Inc. 454, 208
03/05/2015 Hospira   Sodium Chloride Injection, USP   Particulate matter Hospira, Inc. 454, 208
02/25/2015 Heritage   Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial   Lack of Sterility Assurance Heritage Pharmaceuticals Inc. 208
02/23/2015 Sagent Pharmaceuticals, Inc.   Product Description Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL   Product sterility potentially impacted Sagent Pharmaceuticals, Inc. 208
02/10/2015 Hospira   Ketorolac tromethamine injection   Particulate matter Hospira, Inc. 454, 208
01/20/2015 Watson Laboratories   0.9% Sodium Chloride Injection, USP, 250 mL   Due to particulate matter Hospira, Inc. 454, 208
01/09/2015 Wallcur   Practi-0.9% Sodium Chloride IV bags & Practi-0.9% Sodium Chloride IV bags filled with sterile distilled water   Products intended for training, simulation and education purposes may have been used outside their intended use Wallcur 208
12/31/2014 Virazole   ribavirin powder for solution   Microbial Contamination Valeant Pharmaceuticals North America LLC 454, 208
12/23/2014 Hospira   MitoXANTRONE   Due to confirmed subpotency and elevated impurity levels. Hospira Inc. 454, 208
12/12/2014 Gastrotec   Combination of Omeprazole and Misoprostol in a paste   Not approved for use as an animal drug Tristar Equine Marketing, LLC. 454, 183, 495, 208
12/11/2014 Baxter   0.9% Sodium Chloride Injection USP   Contains Particulate Matter Baxter International Inc. 454, 208

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Page Last Updated: 11/26/2015
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