Kanec USA recalls supplement at heels of FDA crackdown

DAVIE, Fla. As an example of how today’s Food and Drug Administration is enforcing dietary supplement regulation, Kanec USA earlier this month voluntarily recalled its Stud Capsule For Men.

The recall was announced following an FDA communication alerting Kanec to the fact that their sexual health dietary supplement had been found to be adulterated with sildenafil — and FDA-approved prescription medication used in the treatment of erectile dysfunction — which consequently reclassified the supplement as an unapproved new drug.

FDA posted that recall on its site earlier this week.

According to Kanec, Stud Capsule For Men were sold nationwide as a blister pack containing one capsule per unit of use 24-packs in a box in both retail outlets and as part of its direct response program, the company stated.