Regeneca Inc. is voluntarily recalling its single-capsule RegenErect dietary supplement because it contains an unlisted product used to correct male erectile dysfunction, the Irvine, California, company said.
The capsules contain tadalafil, making them unapproved new drugs, and tadalafil is not listed in the label, the company said in a Friday statement carried on the Food and Drug Administration website.
Tadalafil is used as a treatment for male erectile dysfunction. It may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels, the statement said.
Regeneca has distributed RegenErect via Internet sales and as samples at public events.
The company did not say if there had been any reports of adverse reactions.