FDA said that the sildenafil may interact with prescription drugs known as nitrates, including nitroglycerin and can dangerously lower blood pressure.
The FDA is investigating the reported death of a 26-year old man, possibly associated with the use of Vigor-25.
FDA Center for Drug Evaluation and Research Office of Compliance director Deborah Autor said that the product is dangerous to consumers because it claims to contain only natural ingredients when it actually contains a prescription drug ingredient.