Medication Monitor



Generic Name (Trade Name—Company)
Notes
October 25, 2018

Weight loss supplement

(Zero Xtreme—Fat Burners Zone)
Zero Xtreme weight loss product contains undeclared sibutramine

Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme capsules in response to an FDA analysis that found the product contains sibutramine, an appetite suppressant that was withdrawn from the U.S. market because of safety concerns. The presence of sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Sibutramine is the active pharmaceutical ingredient in Meridia, a drug approved by FDA in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated that sibutramine poses an increased risk of heart attack and stroke. 

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. 

This tainted product is marketed as a dietary supplement for weight loss and is packaged in gray aluminum bottles with gray aluminum caps, 30 capsules per bottle. The affected Zero Xtreme lot, #1220062085, expires 03/2020. Zero Xtreme was distributed nationwide via the internet through the website fatburnerszone.com.

To date, Fat Burners Zone has not received any reports of adverse events related to this recall.

Fat Burners Zone is notifying its distributors and customers by a recall letter sent by e-mail and is arranging for return/replacement of all recalled products.