I wanted to take OxyELITE Pro to help me lose weight, but I notice this product has been recalled. Why was it recalled?
Two versions of OxyELITE Pro have been removed from the market in the past year. The first version contained 1,3-dimethylamylamine (DMAA). Following the Food and Drug Administration (FDA) announcement in April 2013 about DMAA, dietary supplements containing the ingredient—including the OxyELITE Pro product—can no longer be sold in the U.S. For more information, visit the OPSS FAQ about DMAA on HPRC’s website, as well as HPRC’s list of Dietary Supplement Products Containing DMAA.
The second version of OxyELITE Pro contained the ingredient aegeline, which appears to be a “new dietary ingredient” for which, according to FDA, there is no documented safety information or history of prior use. At least 50 reports of liver illness and failure have been linked to this new version of OxyELITE Pro as well as another product, VERSA-1, which also contains aegeline. For more information about aegeline, see the OPSS FAQ.
In November 2013 FDA sent a warning letter to USPlabs, the manufacturer of OxyELITE Pro and VERSA-1, asking for voluntary recall of these products, and USPlabs complied. For more information about FDA’s investigations of OxyElite Pro, see the FDA information page.