Organic Herbal Supply Inc. is conducting a sweeping nationwide recall of all lots of select sexual enhancement dietary supplements for both men and women because they contain undeclared drugs that pose a health risk to some consumers.
Brand name dietary supplements affected by the recall include Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules. A Food and Drug Administration (FDA) analysis found the products to contain tadalafil, the active drug ingredient found in the prescription erectile dysfunction drug Cialis.
The recall also affects Zrect for Women and LabidaMAX, because a laboratory analysis found the products to contain filbanserin, the active ingredient in the prescription hypoactive sexual desire disorder (HSDD) treatment for women called Addyi.
Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, and Enhancerol Natural Male Enhancement capsules are marketed as a dietary supplement for erectile dysfunction. They are packaged in 2-, 4- and 10-count packages and sold nationwide. Zrect for women and LabidaMAX were packaged in 30-count packages and sold nationwide through Amazon.com and through Zrect.com. Organic Herbal began shipping this product on or around December 2014 through February 2017.
The FDA cautions that use of these products may be harmful to some consumers. The active ingredients tadalafil and filbanserin may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Individuals with diabetes, high cholesterol, high blood pressure or heart disease often take nitrates.
Anyone who has these products in their possession should stop using them and return any unused supplements to the company for a refund. Any adverse events experienced while taking these products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.