CLASS I Drug recall · Reported 13 May 2015 · FDA Enforcement Report
Ultra ZX Dietary Supplement (Extracto de Naranjo Amargo recalled
Ultra ZX Supplements is recalling Ultra ZX Dietary Supplement (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen, distributed nationwide in the US. The recall was initiated on 10 Mar 2015 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0991-2015
- FDA event ID
- 70661
- Recalling firm
- Ultra ZX Supplements, Miami, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 Mar 2015
- FDA classified
- 5 May 2015
- Reported
- 13 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
Timeline
| 10 Mar 2015 | Recall initiated by company | |
| 5 May 2015 | Classified by FDA | +56 days |
| 13 May 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico Foreign: Spain and Ecuador
Questions about this recall
Why was it recalled?
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
Which lots are affected?
All lots/codes/bottles/packages.
Where was it sold?
Nationwide and Puerto Rico Foreign: Spain and Ecuador
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.