USPlabs LLC is recalling certain OxyElite Pro dietary supplement products after a letter from the FDA stated that the products have been linked to liver illnesses and that there is reasonable probability that the products are adulterated.
The affected products include various packaging sizes of OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, and OxyElite Pro Super Thermo Powder. For the full list of recalled products, visit the FDA Safety Alert Page.
The FDA informed USPlabs that OxyElite Pro and another dietary supplement called VERSA-1 were adulterated after discovering they contained aegeline. Aegeline, a new dietary ingredient, lacks a history of use or other evidence of safety. The FDA is not aware of any information demonstrating that aegeline was lawfully marketed as a dietary ingredient in the United States before October 15, 1994.
The FDA had also notified USPlabs about findings indicating a link between the use of the OxyElite Pro products and liver illnesses reported in Hawaii, as well as other states. Over half of the medical records from the Hawaii Department of Health indicated that those patients had taken an OxyElite Pro product prior to becoming ill.
Consumers are advised not to use any dietary supplements labeled OxyElite Pro or VERSA-1.
For more information call (888) 463-6332 or visit the FDA Safety Alert Page.