The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1147-2016·Announced 2016-07-13

SLIM TRIM U Capsules Recalled for Undeclared Sibutramine

Bee Extremely Amazed LLC is recalling SLIM TRIM U Capsules because they contain undeclared sibutramine, a withdrawn drug.

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

Bee Extremely Amazed LLC is recalling SLIM TRIM U Capsules, 250mg, 60-count bottles, manufactured for Floyd Nutrition. The product was marketed as a dietary supplement but was found to be tainted with undeclared sibutramine.

Sibutramine is an appetite suppressant that was previously withdrawn from the US market for safety reasons. Its presence makes the product an unapproved drug, as it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The recall covers all lots of the product, which was distributed nationwide. Consumers should stop using the product and contact the recalling firm for instructions on disposal or return.

The recalled product

Product
SLIM TRIM U Capsules, 250mg, 60-count bottles, 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 →

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