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Drug recall · FDA · Published October 15, 2018

Zero Xtreme USA recalls Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA

Zero Xtreme USA recalls 30-count dietary supplement capsules due to undeclared sibutramine, a weight-loss drug not approved for sale in the US.

🇺🇸 FDA recall #D-0246-2019DrugZero Xtreme ›
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Contact the company & request your remedy

Recalling firmZero Xtreme USA20533 Biscayne Blvd # 825 · Aventura, FL 33180-1529
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Zero Xtreme USA is recalling 30-count dietary supplement capsules because they contain sibutramine without proper FDA approval. This poses a risk of serious health effects if taken without authorization. Read more at govinfonow.com/recall/39505-zero-xtreme-dietary-supplement-recall-undeclared-sibutramine-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39505-zero-xtreme-dietary-supplement-recall-undeclared-sibutramine-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0246-2019

Cite this page

“Zero Xtreme Dietary Supplement Recall: Undeclared Sibutramine Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39505-zero-xtreme-dietary-supplement-recall-undeclared-sibutramine-risk. Based on FDA recall #D-0246-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0246-2019%22&limit=1).

Why it’s dangerous

Sibutramine is a weight-loss drug that was banned by the FDA in 2010 due to serious health risks. The product was marketed without proper approval, meaning it could contain unsafe levels of this substance.

Who’s affected

People who purchased Zero Xtreme Dietary Supplement 30-count capsules between the production date of 2020-06-20 and expiration date of 2020-03-01 are affected. Those who have taken the product without knowing it contains undeclared sibutramine are at higher risk.

How to tell if you have this one

Check for the product name 'Zero Xtreme Dietary Supplement 30-count capsules' and lot number 1220062085 with an expiration date of 03/2020.

  • Brand
    Zero Xtreme
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number 1220062085 and expiration date 03/2020 on the packaging.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product was marketed without FDA approval and contains undeclared sibutramine, which is banned in the US. It is not safe to use as intended.

What should I do if I have this product?

The recall does not specify a remedy, so check the product details and contact the manufacturer for guidance.

Why was this product recalled?

The product was recalled because it contains sibutramine without proper FDA approval, which is illegal and poses health risks.

Take action

Contact Zero Xtreme

We’ve drafted a message you can send Zero Xtreme to request your refund or repair — edit it as you like.

Subject: Recall D-0246-2019 — Zero Xtreme Zero Xtreme

Hello,

I own a Zero Xtreme that is covered by recall D-0246-2019 from Zero Xtreme.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0246-2019 (October 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0246-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA