Ultimate Body Tox PRO capsules — Class I drug recall D-0210-2017
Terminated recall by Ultimate Body Tox, reported 2016-12-28, distributed nationwide. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramin
| Recall number | D-0210-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultimate Body Tox, Rowland, NC, United States |
| Recall initiated | 2016-11-13 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-07-27 |
| Distributed | Nationwide (US) |
| Quantity | 25 bottles |
| Reason classes | undeclared allergen, unapproved 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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0210-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.