Risk of Liver Damage Prompts Recall of Popular Dietary Supplement
USPlabs LLC has announced a nationwide recall of ALL lots and sizes of its OxyElite Pro dietary supplement products. These products contain Aegeline, a synthesized version of a natural extract from the Bael tree.
Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, and hepatitis. Several patients have required liver transplants.
The recalled products were distributed nationwide through retail stores, mail orders and direct delivery.
In addition to the recall of OxyElite Pro products, USPLabs assured Food and Drug Administration (FDA) officials that it will destroy warehouse stocks of the supplement, with a retail value of about $22 million. The FDA will oversee this process.
"As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention (CDC)," said Daniel Fabricant, Ph.D., director of FDA's Division of Dietary Supplement Programs. "Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace."
The FDA used new enforcement tools provided by the FDA Food Safety Modernization Act to act quickly in the face of a potential danger to public health.
The supplement was advertised as an aid to losing weight and building muscles. The FDA warned the company on Oct. 11, 2013, that certain OxyElite Pro products and another supplement, VERSA-1, are considered adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.
While the FDA's investigation is still ongoing, the agency continues to warn consumers to avoid using OxyElite Pro and VERSA-1.
No other products produced by USPlabs are affected by this recall. Consumers who have purchased the products should immediately discontinue use and return the product to the place of purchase for a refund. Contact your health care professional if you have experienced any adverse effects.
For further information on this recall, contact USPlabs toll-free at 800-890-3067.
Consumers should report all adverse effects associated with the use of OxyElite products to the FDA's MedWatch Adverse Event Reporting Program.