CLASS II Drug recall · Reported 21 Nov 2018 · FDA Enforcement Report
Zero Xtreme Dietary Supplement capsules recalled
Zero Xtreme U is recalling Zero Xtreme Dietary Supplement capsules, distributed nationwide in the US. The recall was initiated on 15 Oct 2018 and the FDA has classified it as Class II.
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-0246-2019
- FDA event ID
- 81436
- Recalling firm
- Zero Xtreme U, Aventura, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Oct 2018
- FDA classified
- 15 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 15 Oct 2018 | Recall initiated by company | |
| 15 Nov 2018 | Classified by FDA | +31 days |
| 21 Nov 2018 | Published in enforcement report | +6 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: Undeclared Sibutramine
Product as listed by the FDA
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Where it was distributed
Nationwide within the USA.
Questions about this recall
Is Zero Xtreme Dietary Supplement capsules recalled?
Yes. Zero Xtreme U recalled Zero Xtreme Dietary Supplement capsules on 15 Oct 2018. The recall is Class II and its status is Terminated. Recall number D-0246-2019.
Why was it recalled?
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
Which lots are affected?
Lot: 1220062085 Exp. 03/2020
Where was it sold?
Nationwide within the USA.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.