Regeneca has issued a voluntary recall of all lots of single capsule packet RegenErect, labeled as a dietary supplement.

RegenErect is a blue capsule sold individually in foil packets with a UPC code of 816860010055.

The company has confirmed the presence of Tadalafil, an FDA-approved drug used as treatment for male erectile dysfunction, making these products unapproved new drugs.

The active drug ingredient is not listed on the label for these products, the company said.

The products 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.