CLASS I Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report
PRO capsules, Proprietary Blend, 350 mg recalled by Ultimate Body Tox
Ultimate Body Tox is recalling PRO capsules, Proprietary Blend, 350 mg, distributed nationwide in the US. The recall was initiated on 13 Nov 2016 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0210-2017
- FDA event ID
- 75832
- Recalling firm
- Ultimate Body Tox, Rowland, NC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 Nov 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
Timeline
| 13 Nov 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +39 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
Where it was distributed
Product distributed in NC and nationwide through the internet.
Questions about this recall
Why was it 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.
Which lots are affected?
All lots and manufacturing dates.
Where was it sold?
Product distributed in NC and nationwide through the internet.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Pro recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentol recalled | Ranier's Compounding Laboratory | Sterility | PA |