Zero Xtreme Recall: Undeclared Sibutramine in Weight Loss Capsules
Zero Xtreme recalls 30-count dietary supplement capsules due to undeclared sibutramine. Check your lot number and expiration date for safety details.
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Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
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What happened, in plain English
Zero Xtreme USA is recalling its Zero Xtreme Dietary Supplement, a 30-count bottle of capsules, because it contains undeclared sibutramine. Sibutramine is a drug ingredient that was withdrawn from the market due to safety concerns, and its presence in an over-the-counter supplement poses unexpected health risks. The product was distributed nationwide within the USA. Read more at govinfonow.com/recall/39505-zero-xtreme-recall-undeclared-sibutramine-in-weight-loss-capsules.
Source Summary by GovInfoNow · govinfonow.com/recall/39505-zero-xtreme-recall-undeclared-sibutramine-in-weight-loss-capsules · Updated October 11, 2026 · FDA enforcement record: FDA #D-0246-2019
Cite this page
“Zero Xtreme Recall: Undeclared Sibutramine in Weight Loss Capsules.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39505-zero-xtreme-recall-undeclared-sibutramine-in-weight-loss-capsules. 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
The supplement contains sibutramine, a prescription drug that was removed from the market because it can increase the risk of heart attack and stroke. Because this ingredient is undeclared, consumers are unaware they are ingesting a potent medication with potential serious cardiovascular side effects.
Who’s affected
Consumers who purchased Zero Xtreme Dietary Supplement capsules, specifically those with Lot number 1220062085 and an expiration date of 03/2020, are affected. Individuals seeking weight loss or dietary supplements may be at risk due to the undeclared pharmaceutical ingredient.
How to tell if you have this one
Look for Zero Xtreme Dietary Supplement in 30-count capsules. Check the label for Lot number 1220062085 and an expiration date of 03/2020. The product was sold nationwide within the USA.
- Brand
Zero Xtreme- Category
Drug
What to do — step by step
Stop using the supplement
Do not consume any more capsules from the recalled bottles due to the presence of undeclared sibutramine.
Discard or return the product
The recall record does not specify a return address or disposal method, so please contact Zero Xtreme USA directly for instructions.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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 qwen3.6:35b-a3b on October 11, 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.