The Recall Desk
SevereFDA (Drugs)·D-0884-2016·Announced 2016-06-01

FDA Recalls Black Ant Supplements Marketed Without Approval

The FDA is recalling Black Ant supplements distributed by R Thomas Marketing, LLC because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

What this means for you

Illness, injury, or structural failure has been reported. 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 per the rubric mandates a minimum score of 4 (Severe) due to the potential for serious adverse health consequences or death.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Black Ant, a dietary supplement product packaged in a Big Box containing 20 small boxes with 4 capsules each (80 capsules total). The product is distributed by R Thomas Marketing, LLC, located in Bronx, NY 10467.

The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This indicates that the product has not undergone the FDA's review process to ensure its safety, efficacy, and quality for its intended use.

The product was distributed nationwide via Internet sales. All lots of the product are affected. Consumers who have purchased this product should stop using it and contact the distributor for further instructions or a refund.

The recalled product

Product
Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

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)

  • all lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 24 recalled by R Thomas Marketing, LLC 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 24 products in this recall →

Same manufacturer · R Thomas Marketing, LLC

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