US Drug Recall Register
Class I · High risk Terminated Initiated Nov 13, 2016 (10 years ago)

Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.

What was recalled

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

Recalling firm
Ultimate Body Tox
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0210-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.