The FDA has announced the recall of a single capsule packet RegenErect, as it has been discovered that an active drug ingredient is not listed on the label.
Labeled as a dietary supplement, it has been determined that RegenErect contains Tadalafil, an FDA-approved drug used as a treatment for male Erectile Dysfunction (ED). The use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Erectile Dysfunction is a common problem in men with these conditions, and as such, consumers may seek these types of products to enhance sexual performance.
RegenErect has been sold over the internet to consumers in the United States of America and Puerto Rico and given as samples at public events. It is a blue capsule and sold individually in foil packets with a UPC code of 816860010055.