Agency classClass IOur severity:Critical FDA (Drugs)·D-1223-2014·Announced 2014-04-16

FDA Recalls Vicerex Male Sexual Enhancer for Undeclared Tadalafil

The FDA is recalling Vicerex male sexual enhancer capsules because laboratory analysis found undeclared tadalafil, an unapproved drug ingredient.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Vicerex A Powerful And Fast Acting Male Sexual Enhancer, a dietary supplement sold in boxes of 10 capsules. The product is distributed by Vicerex.com and manufactured by American Lifestyle.Com. The recall covers all lots with UPC 893490820087.

The recall was initiated because FDA laboratory analysis determined that the Vicerex product contains undeclared tadalafil. Tadalafil is an FDA-approved drug used to treat male erectile dysfunction. Because the product contains this unapproved drug ingredient, it is considered an unapproved new drug rather than a dietary supplement. The source text notes that a related product, Black Ant, contains undeclared sildenafil, but this recall specifically addresses the Vicerex product.

Thirteen boxes were distributed domestically and 50 boxes were distributed internationally to consumers. International distribution includes, but may not be limited to, Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, and Oman. Domestic distribution is currently under investigation. Consumers should stop using the product and contact the distributor for further instructions.

The recalled product

Product: Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com.
Manufacturer: American Lifestyle.Com
Category: Drug — Dietary Supplement
Hazard: undeclared-drug
unapproved-new-drug

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

All lots
UPC 893490820087

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by American Lifestyle.Com under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · American Lifestyle.Com

See all →

Severe
FDA Recalls Black Ant Supplement Containing Undeclared Sildenafil
FDA (Drugs) · 2014-04-16

Same hazard · undeclared drug