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Question

I wanted to take OxyELITE Pro to help me lose weight, but I notice this product has been recalled. Why was it recalled?

    OPSS Answer

    Three 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.

    FDA warned consumers not to use two products with aegeline: OxyELITE Pro and VERSA-1. The manufacturer issued a recall of OxyELITE Pro, discontinued both products, and destroyed its warehouse stock.

    FDA recently tested a third version (Lot # 216732, Exp 04/17) and found it to contain the prescription drug Fluoxetine, which is used for treating depression, bulimia, obsessive-compulsive disorder, and other conditions. FDA is advising consumers not to purchase or use OxyELITE Pro Super Thermogenic. Please see the FDA public notification for more information.

    FAQ updated 3 March 2015