FDA Discovers Active Drugs in Several Supplements, Orders Recall

The undeclared ingredients may cause blood pressure to lower, raise risk of hypotension and syncope
The undeclared ingredients may cause blood pressure to lower, raise risk of hypotension and syncope

The Food and Drug Administration (FDA) has ordered a nationwide recall of several dietary supplements manufactured by Organic Herbal Supply, Inc. after an analysis of the contents showed these products contained active pharmaceutical ingredients that may pose a threat to consumers.

Specifically, the company is recalling the following products because they were found to contain tadalafil, a phosphodiesterase type 5 inhibitor, FDA-approved for the treatment of erectile dysfunction: Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement. The use of supplements that include undeclared tadalafil can be harmful to individuals as they can interact with nitrates found in some prescription medications and may lower blood pressure to dangerous levels. 

Related Articles

In addition, FDA analysis has found the active ingredient flibanserin in two of the company's products: Zrect for Women and LabidaMAX. Flibanserin is an FDA-approved prescription medication for the treatment of hypoactive sexual desire disorder in women. The drug carries a boxed warning which states that alcohol should not be consumed with flibanserin as the combination may increase the risk of severe hypotension and syncope in the patient. 

Currently, the FDA is not aware of any reports of illness related to these supplements. Consumers who have taken these products and have experienced a problem should contact their healthcare practitioner. Adverse reactions may be reported to the FDA's MedWatch Adverse Event Reporting program.

For more information visit FDA.gov.