ULTRA ZX DIETARY SUPPLEMENT — Class I drug recall D-0991-2015
Terminated recall by Ultra ZX Supplements, reported 2015-05-13, distributed nationwide. Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sib
| Recall number | D-0991-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultra ZX Supplements, Miami, FL, United States |
| Recall initiated | 2015-03-10 |
| Classified | 2015-05-05 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2018-04-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | EC, ES |
| Quantity | 636 bottles |
| Reason classes | undeclared allergen, unapproved product |
Product
ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
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-0991-2015. 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.