Organic Herbal Supply Inc., has issued a nationwide recall of all lots of XtraHRD Natural Male Enhancement capsules after a Food and Drug Administration (FDA) analysis found that the dietary supplements contained a hidden drug ingredient, Tadalafil, the active ingredient in the prescription erectile dysfunction drug Cialis. This drug poses serious health risks to men who take nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
The recall comes about two weeks after the FDA warned consumers not to purchase or use XtraHRD supplements because of the potentially dangerous undeclared drug ingredient found in the product.
Organic Herbal Supply said that customers who have XtraHRD in their possession should stop using it and return any unused product directly to the company for a full refund. Customers can call 855-429-7328 with questions.
Anyone who has used these products and suffered adverse events should contact their doctor. Any side effects should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm. To date, no adverse events related to these recalled products have been reported.
The FDA is advising the public of a growing trend in dietary supplements and conventional foods with hidden drugs and chemicals that can pose risks to consumers. These products are typically promoted for sexual enhancement, weight loss and bodybuilding, and are often represented as “all natural.”