FDA Drug recall D-0991-2015
ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 cap…
- FDA Drug
- Class I
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class I recall of ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 cap… by Ultra Zx Supplements, citing marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0991-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-03-10 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ultra Zx Supplements |
| Distribution | US |
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
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
Identifiers
| code_info | All lots/codes/bottles/packages. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0991-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.