X-Hero, Male Enhancer Supplements Recalled

USA Far Ocean Group Inc., is recalling the company's two supplement products sold under the names X-Hero and Male Enhancer.

The company took the action after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of X-Hero sample found the product contains sulfosildenafil, the analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making X-Hero an unapproved drug.

In addition, FDA analysis of Male Enhancer sample found the product contains tadalafil, the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making Male Enhancer an unapproved drug.

FDA advised that both products pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that either sulfosildenafil or tadalafil may cause side effects, such as headaches and flushing.

These two products have been distributed nationwide via retail stores, internet sales and mail order. All of the following packages of X-Hero and Male Enhancer products are involved in this voluntary recall:

Consumers who have X-Hero or Male Enhancer in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.