The Recall Desk
CriticalFDA (Drugs)·D-1141-2016·Announced 2016-07-13

Bee Extremely Amazed LLC Recalls Infinity Capsules Tainted With Sibutramine

Bee Extremely Amazed LLC is recalling Infinity Capsules because the product was found to contain undeclared sibutramine, a withdrawn appetite suppressant.

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

Bee Extremely Amazed LLC is voluntarily recalling Infinity Capsules, 500 mg, 30-count bottles, manufactured for Floyd Nutrition. The recall covers all lots of the product, which was distributed nationwide.

The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Although marketed as a dietary supplement, the product was found to be tainted with undeclared sibutramine. Sibutramine is an appetite suppressant that was previously withdrawn from the US market for safety reasons, making its presence in this product an unapproved drug.

Consumers who have purchased Infinity Capsules should stop using the product immediately. The source text does not provide specific instructions for disposal or refund procedures, but consumers should generally follow guidance from the recalling firm or the FDA regarding the safe handling of recalled medications and supplements.

The recalled product

Product
Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition

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 14 recalled by Bee Extremely Amazed 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 14 products in this recall →