Stop using now Drug recall · FDA · Published July 2, 2015

Zero Xtreme Fat Burner Recall: Hidden Sibutramine Hazard

FDA recalls Zero Xtreme High Performance Fat Burner capsules due to undeclared sibutramine. Check your lot number and expiration date immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1165-2016Drug Zero Xtreme ›

Stop using this now

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

Take action

Contact the company

Recalling firmXTREME Z DISTRIBUTORS INC3300 NE 191st St Apt 813 · Aventura, FL 33180-2444

✎ GovInfoNow plain-language explainer

Xtreme Z Distributors Inc is recalling Zero Xtreme High Performance Fat Burner capsules because they contain the banned prescription drug sibutramine. The FDA confirmed this through sampling, meaning the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Sibutramine has been linked to serious cardiovascular events and is not allowed in over-the-counter weight loss supplements. Read more at govinfonow.com/recall/44109-xtreme-z-distributors-inc-recalls-zero-xtreme-high-performance-fat.

Source Summary by GovInfoNow · govinfonow.com/recall/44109-xtreme-z-distributors-inc-recalls-zero-xtreme-high-performance-fat · Updated October 12, 2026 · FDA enforcement record: FDA #D-1165-2016

Cite this page

“Zero Xtreme Fat Burner Recall: Hidden Sibutramine Hazard.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44109-xtreme-z-distributors-inc-recalls-zero-xtreme-high-performance-fat. Based on FDA recall #D-1165-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1165-2016%22&limit=1).

The Food and Drug Administration announced on July 2, 2015, that Xtreme Z Distributors Inc. is voluntarily recalling Zero Xtreme High Performance Fat Burner capsules due to the presence of undeclared sibutramine. The agency stated the product was marketed without an approved New Drug Application.

How to tell if you have it

Brand: Zero Xtreme
Product: High Performance Fat Burner Capsules, 30-count bottle
Distributor: Xtreme Z Distributors, Inc., Miami, FL 33180
Lot code: 1220062085
Expiration date: 09/16
Units affected: 70,350 capsules

The hazard

FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine in the capsules. The product was classified as a Class I recall, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.

Context

GovInfoNow's records show other recent recalls of similar products include StuffbyNainax MR 7 SUPER 700000 Capsules (2025-12-15) and Zydus Clomipramine Capsules Recall (2025-10-22). Xyvona (Levorphanol) 2mg Tablet Recall occurred on 2026-05-22 due to FDA denial of marketing.

How to tell if you have this one

Look for a 30-count bottle of Zero Xtreme High Performance Fat Burner capsules distributed by Xtreme Z Distributors Inc., Miami, FL. Specifically check the lot number 1220062085 and the expiration date 09/16.

Brand
Zero Xtreme
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop using the product
Do not consume any capsules from the recalled bottles due to the presence of undeclared sibutramine.
Check your lot number
Verify if your bottle has Lot 1220062085 and Exp. 09/16 to confirm it is part of this recall.
Dispose of the product
Safely discard any remaining capsules from the affected lots to prevent accidental ingestion.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 12 months after the firm started it.

Jul 2, 2015Firm started the recall
Jul 6, 2016FDA classified it Class I
Jul 13, 2016Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/44109-xtreme-z-distributors-inc-recalls-zero-xtreme-high-performance-fat">Zero Xtreme Fat Burner Recall: Hidden Sibutramine Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1165-2016 (July 2, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1165-2016 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.