Zero Xtreme High Performance Fat Burner capsules — Class I drug recall D-1165-2016
Ongoing recall by XTREME Z DISTRIBUTORS INC, reported 2016-07-13, distributed nationwide. Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and des
| Recall number | D-1165-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | XTREME Z DISTRIBUTORS INC, Aventura, FL, United States |
| Recall initiated | 2015-07-02 |
| Classified | 2016-07-06 |
| Reported by FDA | 2016-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 70,350 capsules |
| Reason classes | unapproved product |
| Lot numbers | 09/16, 1220062085 |
Product
Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
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-1165-2016. 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.