Agency classClass IOur severity:Severe FDA (Drugs)·D-1224-2014·Announced 2014-04-16

FDA Recalls Black Ant Supplement Containing Undeclared Sildenafil

The FDA is recalling Black Ant dietary supplements because laboratory analysis found they contain undeclared sildenafil, an FDA-approved drug for erectile dysfunction.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Black Ant, 4600 mg x 4, a dietary supplement marketed by American Lifestyle.Com. Laboratory analysis conducted by the FDA determined that the product contains undeclared sildenafil. Sildenafil is an FDA-approved drug used to treat male erectile dysfunction (ED). Because the product contains an undeclared active pharmaceutical ingredient, it is considered an unapproved new drug.

The recall involves all lots of the product identified by UPC 4026666142546. The product is packaged in a small green box with gold lettering on the front and mostly foreign characters on the back. Inside, there are four capsules individually wrapped in black and red plastic with white lettering. The source text notes that product numbers may vary for the same product identification and packaging.

Distribution of the product included 3 boxes domestically and 4 boxes internationally. International distribution included, 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 manufacturer or the FDA for further instructions.

The recalled product

Product: Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC…
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 4026666142546.

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 →

Critical
FDA Recalls Vicerex Male Sexual Enhancer for Undeclared Tadalafil
FDA (Drugs) · 2014-04-16

Same hazard · undeclared drug