Zero Xtreme Dietary Supplement 30-count capsules — Class II drug recall D-0246-2019
Terminated recall by Zero Xtreme USA, reported 2018-11-21, distributed nationwide. Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
| Recall number | D-0246-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zero Xtreme USA, Aventura, FL, United States |
| Recall initiated | 2018-10-15 |
| Classified | 2018-11-15 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2022-01-18 |
| Distributed | Nationwide (US) |
| Quantity | 16 bottles |
| Reason classes | undeclared allergen, unapproved product |
| Lot numbers | 1220062085 |
| Expiration dates | 2020-03 |
Product
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Reason for recall
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
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-0246-2019. 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.