FDA Drug recall D-0210-2017
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York…
- FDA Drug
- Class I
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class I recall of Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York… by Ultimate Body Tox, citing marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from t….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0210-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-11-13 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ultimate Body Tox |
| Distribution | US |
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
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.
Identifiers
| code_info | All lots and manufacturing dates. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0210-2017%22
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