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FDA MedWatch Alerts

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Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

March 21, 2017

Audience: Plastic Surgery, Oncology, Patient. ISSUE: FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of b...

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Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

March 15, 2017

Audience: Gatroenterology, Patient. ISSUE: FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive...

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SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

March 14, 2017

Audience: Risk Manager, Patient. ISSUE: Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid f...

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Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices

March 9, 2017

Audience: Consumer. ISSUE: Regeneca Worldwide, a division of VivaCeuticals, Inc. is conducting a nationwide recall of its entire line of herbal and dietary supplement products pursuant to a Consent Decree entered by the federal court for the Central District of California. This recall applies to all products manufactured and sold between June 1, 2011 and February 8, 2017. These products include, but are not limited...

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Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient

March 8, 2017

Audience: Consumer. [Posted 03/07/2017] ISSUE: A&H Focal Inc. is voluntarily recalling all lots marketed as dietary supplements for male sexual enhancement from January 2014 to present. These products have been historically tested by the FDA and found to contain PDE-5 Inhibitors (i.e.sildenafil, tadalafil, vardenafil, etc.) which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED),...

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Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance

February 27, 2017

Audience: Urology, Pharmacy, Patient. ISSUE: Endo Pharmaceuticals Inc. is recalling one lot of Edex (alprostadil for injection) 10 mcg to the consumer level. This product recall is due to the detection by Endo of a defect in the crimp caps used in the manufacture of the subject product lot. This defect has the potential to lead to a loss of container closure integrity, which could impact the product’s sterility a...

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Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall - Products May Contain Synthetic or Natural Latex

February 25, 2017

Audience: Pharmacy, Risk Manager. [Posted 02/24/2017] ISSUE: Advanced Pharma, Inc. d/b/a Avella of Houston, is conducting a voluntary recall of all unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location between September 1, 2016 and February 16, 2017 to the user level (hospitals and institutions) because such products may contain synthetic latex an...

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XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient

February 22, 2017

Audience: Consumer. [Posted 02/22/2017] ISSUE: Organic Herbal Supply, Inc. is conducting a voluntary nationwide recall of all lots of XtraHRD Natural Male Enhancement capsules. FDA analysis has found the product to contain Tadalafil. Tadalafil is a FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredients are not listed on the label for this product. Use of this product...

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HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance

February 15, 2017

Audience: Consumer. [Posted 02/15/2017] ISSUE: Synergy Rx Pharmacy recalled all lots of Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial to the retail level due to a lack of sterility assurance. This recall impacts all sterile products distributed between 06/01/2016 and 12/22/2016. The product was only distributed to physician offices and clinics in Arizona, California, Wisconsin, and...

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Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter

February 9, 2017

Audience: Pediatrics, Cardiology, Critical Care Medicine. ISSUE: Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, Inc., is voluntarily recalling lot number PLND1613 of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL), vials to the hospital or user level. Some of the vials have been found to contain particulate matter. Particulate matter has the potential to block blood vessels, provoke...

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Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids

February 9, 2017

Audience: Consumer, Emergency Medicine. [Posted 02/09/2017] ISSUE: Kingsway Trading Inc. is recalling its 1.06 oz (30g) bottles of “Well Balance Xanthium & Siler Combo (Bi Yan Pian)” Batch No. 130401 & Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including hea...

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Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions

February 2, 2017

Audience: Nursing, Surgery, Dentistry, Patient. ISSUE: FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. See the FDA Drug Safety Communication for a data summary. As a result, FDA is...

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Certain Homeopathic Teething Products: FDA Warning- Confirmed Elevated Levels of Belladonna

January 27, 2017

Audience: Consumer. ISSUE: FDA announced that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products. In...

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Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial

January 25, 2017

Audience: Pharmacy. ISSUE: Hospira, Inc. is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. The product is packaged in a carton containing 1x100 mL vial. The lot was distributed from August 2016 through...

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Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised

December 16, 2016

Audience: Internal Medicine, Pharmacy, Psychiatry. ISSUE: Based on an FDA review of a large clinical trial that FDA required the drug companies to conduct, FDA determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. The risk of these mental health side effects is still present,...

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General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women

December 14, 2016

Audience: Consumer, Surgery, Anesthesiology. ISSUE: FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains. Consistent with animal studies, recent human studies suggest that a single, relatively short exposure to general a...

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Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer

December 12, 2016

Audience: Internal Medicine, Endocrinology, Urology. ISSUE: As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and FDA has approved label updates to describe the...

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Megajex Natural Male Sex Enhancer by MS Bionic: Recall - Undeclared Drug Ingredients

December 1, 2016

Audience: Consumer. [Posted 12/01/2016] ISSUE: MS Bionic, Inc. announced today that it is conducting a voluntary nationwide recall of all lots of Megajex Natural Male Sex Enhancer capsules. FDA analysis has found the product to contain Tadalafil and Sildenafil. Tadalafil and Sildenafil are FDA-approved drugs used as treatment for male Erectile Dysfunction (ED). The active drug ingredients are not listed on the...

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Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient

December 1, 2016

Audience: Consumer. [Posted 12/01/2016] ISSUE: Ultimate Body–Tox is voluntarily recalling all lots of Ultimate Body Tox PRO capsules to the consumer level. FDA analyses of this product found it to contain undeclared sibutramine. Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in Ultimate Body Tox PRO renders it an u...

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DMAA Net Weight 500g by NutriVitaShop: Recall - Presence of DMAA May Pose Health Risk

November 26, 2016

Audience: Consumer. [Posted 11/26/2016] ISSUE: NutriVitaShop, also doing business as Naturecom Inc. Lake Forest, CA is requesting the nationwide recall of its DMAA net weight 500g because there may be presence of DMAA. Lot numbers include #20141102, 20150715, 20151022, 20160226, 20160701, 20161017 and 20150323. DMAA net weight 500g is packaged in approximately 8" x 11” silver and clear mylar ziplock bags that c...

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