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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Dietary Supplements

Zero Xtreme USA: Zero Xtreme Dietary Supplement Recalled for Undeclared Sibutramine

Agency Publication Date: November 15, 2018
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Summary

Zero Xtreme USA is recalling approximately 16 bottles of Zero Xtreme Dietary Supplement (30-count capsules) because they were found to contain sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in 2010 for safety reasons and is not listed on the product label. This product was distributed nationwide across the United States. You should immediately stop using these capsules and contact your healthcare provider if you have experienced any problems while taking this supplement.

Risk

The undeclared sibutramine in this supplement can substantially increase blood pressure and pulse rate in some people, posing a significant risk to those with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. It may also interact in life-threatening ways with other medications a consumer might be taking.

What You Should Do

  1. Check your supplement bottle for Zero Xtreme Dietary Supplement 30-count capsules with lot number 1220062085 and an expiration date of 03/2020.
  2. Immediately stop using any affected capsules from this specific lot.
  3. Contact your healthcare provider or pharmacist for guidance regarding any health concerns or potential side effects related to this product.
  4. Return any unused product to the place of purchase for a full refund and contact Zero Xtreme USA for further instructions.
  5. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare consultation and refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Zero Xtreme Dietary Supplement (30-count capsules)
Model:
SD2014-0002208
Lot Numbers:
1220062085 (Exp. 03/2020)
Date Ranges: Exp. 03/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81436
Status: Resolved
Manufacturer: Zero Xtreme USA
Manufactured In: United States
Units Affected: 16 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.