Organic Herbal Supply, Inc. announced today that it is conducting a voluntary nationwide recall of all lots of Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules. FDA analysis has found the products to contain Tadalafil. Tadalafil is a FDA-approved drug used as treatment for male Erectile Dysfunction (ED), the presence of tadalafil in these male enhancement products renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Organic Herbal Supply is also recalling Zrect for Women and LabidaMAX. FDA analysis has found these two products contain Flibanserin, an FDA-approved prescription drug for Hypoactive Sexual Desire Disorder (HSDD) in women. There have been no reports of illness to date.
Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, 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.
Use of these products may pose a threat to consumers because the undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Organic Herbal Supply, advises any customers in possession of the Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol, Zrect for Women, LabidaMAX to stop using and return any unused product for a full refund to the company directly. Customers can call 855-429-7328 between the hours of 10 a.m. and 5 p.m. Pacific Standard Time for instructions on the return and refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Organic Herbal Supply Inc. is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. Organic Herbal Supply Inc. promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our brands, products and consumers.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.