BlueFusion could also be tainted with tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein, FDA says. The active ingredients in both supplements may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels; which can be life-threatening, particularly to consumers with diabetes, high blood pressure, high cholesterol or heart disease.
The FDA says the presence of the undeclared active ingredients renders the products unapproved drugs. Sildenafil and tadalafil are FDA approved drugs for the treatment of male erectile dysfunction.
No adverse events have been reported, FDA says. Consumers, distributors and retailers that have the recalled products should stop use or distribution and return to place of purchase.