Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported December 28, 2016
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Ultimate Body Tox recalled Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured … - a critical-severity action.
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured … was recalled by Ultimate Body Tox in December 28, 2016. Reason: Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutrami…. Check the official notice for the remedy. Verify recall #D-0210-2017 with the FDA Drug before acting.
The recall
Ultimate Body Tox issued this critical-severity FDA Drug recall-Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutrami….
- Critical
- severity level
- Class I
- classification
- December 28, 2016
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0210-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0210-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on November 13, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. Ultimate Body Tox is listed as the recalling firm, operating out of Rowland, NC. Federal records list the affected scope as 25 bottles.
The documented reason for this recall is: 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 safet… Distribution data in the federal record shows the product reached: Product distributed in NC and nationwide through the internet.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
25 bottles
Related Recalls
6
5 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0210-2017 |
| Date reported | December 28, 2016 |
| Date initiated | November 13, 2016 |
| Recalling firm | Ultimate Body Tox |
| Firm location | Rowland, NC |
| Affected scope | 25 bottles |
| Distribution | Product distributed in NC and nationwide through the internet. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0210-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product 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.. Recalled by Ultimate Body Tox. Units affected: 25 bottles.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2016. Severity: Critical. Recall number: D-0210-2017.
Where was the recalled product distributed? ▼
Distribution: Product distributed in NC and nationwide through the internet..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0210-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 28, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.