OxyElite Supplements Linked to Deadly Liver Illnesses Recalled

The Texas company USPlabs LLC is recalling a number of its OxyElite Pro dietary supplement products after health officials linked one death and a number of illnesses to them, the Food and Drug Administration (FDA) announced Sunday.

According to the FDA, the company jumped into gear after the FDA issued a letter saying that if it did not recall the products, the agency would halt the distribution of the products through the law. The letter was the second of its kind issued by the FDA under the Food Safety Modernization Act.

"We took this step to ensure that adulterated and harmful products do not reach the American public," Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor said in a statement. "We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public."

The products include OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Pro Super Thermo Powder.

A review of 46 medical records submitted to the FDA by the Hawaii Department of Health showed that 27 patients, or nearly 60 percent, had taken an OxyElite Pro supplement prior to becoming sick. Of that number, 17 said the supplement was the only one they were taking. One patient needed a liver transplant, three are awaiting transplants and one died.

According to the FDA, both OxyElite Pro and a supplement known as VERSA-1 contain a dietary ingredient known as aegeline. Aegeline was not marketed in the United States prior to 1994 and "lacks a history of use or other evidence of safety," the agency said.

The FDA encourages consumers not to use either supplements, and to contact their doctor if they believe they have been harmed through these or any other supplements.