The federal agency said the over-the-counter medicine is an unauthorized product promoted for the treatment of erectile dysfunction.

"Rize 2 contains an undeclared pharmaceutical ingredient similar to the prescription drug sildenafil, which should only be used under the supervision of a health care professional," Health Canada said in a statement. "The product may pose serious health risks, especially for patients with pre-existing medical conditions such as heart problems, those who may be taking heart medications or those who may be at risk for strokes."

Officials said the distributor, Cana International Distributing, is conducting a voluntary recall of all lots of Rize 2 that are available at retail outlets across Canada.

A similar action was recently announced by the U.S. Food and Drug Administration.