Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported December 25, 2013
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss …
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Zi Xiu Tang Success, LLC recalled Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Su… - a critical-severity action.
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Su… was recalled by Zi Xiu Tang Success, LLC in December 25, 2013. Reason: Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingr…. Check the official notice for the remedy. Verify recall #D-370-2014 with the FDA Drug before acting.
The recall
Zi Xiu Tang Success, LLC issued this critical-severity FDA Drug recall-Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingr….
- Critical
- severity level
- Class I
- classification
- December 25, 2013
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-370-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-370-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on October 22, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Zi Xiu Tang Success, LLC is listed as the recalling firm, operating out of Kutztown, PA. Federal records list the affected scope as 16126 bottles.
The documented reason for this recall is: Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety r… Distribution data in the federal record shows the product reached: Nationwide and Canada to distributors and consumers.. 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 - 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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products 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
16126 bottles
Related Recalls
6
0 from same agency
Product description
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
Reason for recall
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-370-2014 |
| Date reported | December 25, 2013 |
| Date initiated | October 22, 2012 |
| Recalling firm | Zi Xiu Tang Success, LLC |
| Firm location | Kutztown, PA |
| Affected scope | 16126 bottles |
| Distribution | Nationwide and Canada to distributors and consumers. |
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-370-2014) 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 Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1. Recalled by Zi Xiu Tang Success, LLC. Units affected: 16126 bottles.
Why was this product recalled? ▼
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 25, 2013. Severity: Critical. Recall number: D-370-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Canada to distributors and consumers..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-370-2014) 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.
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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 25, 2013. 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.