The Recall Desk
CriticalFDA (Drugs)·D-1597-2014·Announced 2014-09-24

Nova Products Recalls Black Ant for Undeclared Sildenafil

Nova Products, Inc. is voluntarily recalling Black Ant capsules because FDA analysis found undeclared sildenafil, an active ingredient in erectile dysfunction drugs.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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

Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant, 4600 mg, four capsules per box. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The recall was initiated because FDA laboratory analysis determined that the capsules contain undeclared amounts of sildenafil. Sildenafil is an active ingredient in FDA-approved drugs used to treat erectile dysfunction.

The product was distributed nationwide to retailers and distributors. Consumers should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA.,

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 (1)

  • 2006-3627878

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Nova Products, Inc. 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 8 products in this recall →