# FDA recall D-0210-2017

> **Ultimate Body Tox** · Class I · drug recall initiated 2016-11-13.

## 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.

## Reason for recall

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.

## Distribution

Product distributed in NC and nationwide through the internet.

## Key facts

- **Recall number:** D-0210-2017
- **Recalling firm:** Ultimate Body Tox
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-11-13
- **Report date:** 2016-12-28
- **Termination date:** 2017-07-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rowland, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0210-2017

## Citation

> AI Analytics. FDA recall D-0210-2017. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0210-2017. Source: US FDA. Licensed CC0.

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