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FDA MedWatch Alerts

FDA Updates on Valsartan Recalls

October 16, 2018

Audience: Consumer, Health Professional, Pharmacy. Investigation ongoing – This page to be updated as more information is available FDA releases additional NDMA/NDEA detection methodUpdate [10/16/2018] FDA is posting a gas chromatography-tandem mass spectrometry (GC-MS/MS) method utilizing liquid injection for detecting the presence of impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in v... Read more

Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine

October 16, 2018

Audience: Consumers. Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme, capsules to the consumer level. FDA analysis has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established... Read more

FDA Alerts Consumers of Sprayology’s Voluntary Nationwide Recall of Homeopathic Water-Based Medicines Due to Microbial Contamination

October 11, 2018

Audience: Consumers. [10/11/2018] The Food and Drug Administration is alerting consumers about a voluntary recall of all lots with expiration dates from October 2018 to July 2022 of Sprayology’s water-based homeopathic product line for human use. These products are labeled as a homeopathic and are being recalled due to microbial contamination at the King Bio Inc. manufacturing facility in Asheville, North C... Read more

FDA Alerts Consumers and Pet Owners of Silver Star Brand’s Voluntary Recall of Homeopathic Drug Products

October 4, 2018

Audience: Consumers, Pet Owners. The Food and Drug Administration is alerting consumers and pet owners about a voluntary recall of certain lots of eight products – six products for humans, including four Native Remedies and two Healthful Naturals, and two PetAlive products for pets – distributed by Silver Star Brands Inc. (Oshkosh, Wisconsin). These products are labeled as a homeopathic and are being recalled due to ... Read more

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

September 28, 2018

Audience: Consumer, Health Professional, Pharmacy. Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which ... Read more

Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication

September 27, 2018

Audience: Consumer, Health Professional, Pharmacy. Audience: Patients and caregivers who use or are considering using pen injectors with pen needles to inject prescription medicines. Health care providers who treat patients, or who train users on pen needles and pen injectors Specialties Health care providers including Nurses, Nurse Practitioners, Physician Assistants, Health Educators,... Read more

FDA alerts consumers not to use products distributed by Years to Your Health

September 14, 2018

Audience: Consumer. [9/14/2018] The U.S. Food and Drug Administration is alerting consumers not to use any products made by Years to Your Health of Irving, Texas. FDA is concerned these products could put consumers at risk for serious infection because they are made in a facility with poor manufacturing practices. Years to Your Health markets hundreds of products online and in its retail store. FDA recently... Read more

FDA Alerts Consumers of BioLyte Laboratories Voluntary Recall of NeoRelief

September 14, 2018

Audience: Consumer. [9/14/2018] The Food and Drug Administration is alerting consumers and health care professionals about a voluntary recall of certain lots (1138, 1139, 1146, and 1160) of NeoRelief distributed by BioLyte Laboratories (Grand Rapids, Michigan). NeoRelief is labeled as a homeopathic topical for the temporary relief of occasional muscle cramps, restlessness and twitching and is being recalled due to... Read more

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

September 10, 2018

Audience: Consumer, Health Professional, Pharmacy. September 10, 2018 -- Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile.  These ... Read more

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride Due to Presence of Precipitate

September 6, 2018

Audience: Consumer, Health Professional, Pharmacy. September 6, 2018 -- SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.Administration of a drug product that may contain precipitate has the pot... Read more

Beaumont Bio Med, Inc. Issues Voluntary Nationwide Recall of all their Homeopathic Aqueous/Alcohol-Based Medicines due to the Nationwide Recall by the Contract Manufacturer, King Bio, of all their Aqueous-Based Products due to Possible Microbial Contamination

September 5, 2018

Audience: Consumer, Health Professional, Pharmacy. Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.Risk Statement: The administration or use of drug products with microbial contamination could... Read more

FDA Announces Voluntary Recall of Montelukast Tablets by Camber Pharmaceuticals Due to Incorrect Drug in Bottles

August 31, 2018

Audience: Consumer, Health Professional, Pharmacy. The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to ins... Read more

SGLT2 (sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

August 29, 2018

Audience: Patient, Endocrinology, Health Professional, Pharmacy. ISSUE: FDA is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. We a... Read more

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

August 29, 2018

Audience: Consumer, Health Professional, Pharmacy. HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been... Read more

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

August 28, 2018

Audience: Consumer, Health Professional, Pharmacy. Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa. Out of an abundance of caution, Product Quest has decided to expand the recall to include all lots of nasal products and baby oral gels currently wi... Read more

King Bio Issues Voluntary Nationwide Recall of All Aqueous-Based Products for Human and Animal Use Due to Possible Microbial Contamination

August 27, 2018

King Bio is voluntarily recalling all of its aqueous-based products for human and animal use (see website link below), within expiry, to the consumer level due to possible microbial contamination.Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to... Read more

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

August 27, 2018

Audience: Consumer, Health Professional, Pharmacy. Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).Pfizer concluded that the use of the product with an unmatched ... Read more

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 mg Due to Labeling Mix-up

August 27, 2018

Audience: Consumer, Health Professional, Pharmacy. Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level.A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a p... Read more

Living Well Remedies, LLC Issues Voluntary Nationwide Recall of Weight Away Remedy, Lot # 111417LWL614, Due To Microbial Contamination

August 24, 2018

Audience: Consumer, Health Professional, Pharmacy. FOR IMMEDIATE RELEASE – Franklin Lakes, NJ, Living Well Remedies, LLC is voluntarily recalling Weight Away Remedy lot# 111417LWL614 to the consumer level. The independent manufacturing facility that produced this lot reported it to be out of specification for microbial testing. Administration or use of drug products with microbial contamination, could potentially r... Read more

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

August 21, 2018

Audience: Consumer, Health Professional, Pharmacy. Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the... Read more

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FDA MedWatch Alerts Archive