The Recall Desk
CriticalFDA (Drugs)·D-0210-2017·Announced 2016-12-28

Ultimate Body Tox PRO capsules recalled for undeclared sibutramine

FDA is recalling Ultimate Body Tox PRO capsules because they contain undeclared sibutramine, a controlled substance removed from the market for safety reasons.

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

The U.S. Food and Drug Administration is recalling Ultimate Body Tox PRO capsules, a proprietary blend manufactured for JSN Health. The product is being recalled because it contains undeclared sibutramine. Sibutramine is a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons.

The presence of sibutramine renders the product an unapproved drug for which safety and efficacy have not been established. The recall covers 25 bottles of the 45-count, 350 mg capsules. All lots and manufacturing dates are affected.

The product was distributed in North Carolina and nationwide through the internet. Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on how to dispose of the product safely.

The recalled product

Product
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
Manufacturer
Ultimate Body Tox
Affected units
25

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 and manufacturing dates.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: