USPlabs LLC, has recalled specific OxyElite Pro dietary supplement products, marketed as an aid to losing weight and building muscles, after receiving a letter from FDA stating that the products have been linked to liver illnesses. FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.
FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.
The FDA reviewed 46 medical records, submitted by the Hawaii Department of Health, and found that 27 patients had taken a dietary supplement labeled as OxyElite Pro before becoming ill. Seventeen of the patients reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.