USPlabs LLC just announced a recall of its OxyElite Pro Dietary Supplements over potential health risks and to now include Raspberry Lemonade OxyElite Pro Super Thermo Powder, among others. The recall includes all lots and sizes of specific dietary supplements, according to the U.S. Food and Drug Administration (FDA).
The recalled products contain aegeline, a synthesized version of a natural extract from the Bael tree. According to the FDA, epidemiological evidence reveals that use of these products has been tied to serious adverse health consequences, such as serious liver damage or acute liver failure. Much of these injuries were seen in Hawaii and investigations continue into a potential causal relationship. The recalled Raspberry Lemonade—an other flavored—OxyElite Pro Super Thermo Powder was distributed nationwide through retail stores, mail orders, and direct delivery.
A complete breakdown of the following recalled products may be accessed on the FDA website here:
- OxyElite Pro Super Thermo capsules
- OxyElite Pro Ultra-Intense Thermo capsules
- OxyElite Pro Super Thermo Powder: Includes fruit punch, blue raspberry, grape bubblegum, green apple, and raspberry lemonade flavors
No other USPlabs products are involved in this recall. Consumers who have purchased the products are advised to immediately discontinue use of the OxyElite products and return the products to the place of purchase for a refund. If any adverse events are experienced, consumers are advised to contact their health care professionals. Consumers may contact USPlabs, toll-free, at 1.800.890.3067, Monday through Friday, from 9:00 a.m. to 5:00 p.m., Eastern Standard Time (EST) or by email at firstname.lastname@example.org. Adverse reactions may be reported to the FDA MedWatch Adverse Event Reporting program online at http://www.fda.gov/medwatch/getforms.htm, by regular mail, or to FDA’s MedWatch Hotline at 1.800.FDA.1088.
Although most of the issues involving OxyElite Pro liver injuries have been concentrated in Hawaii, a San Diego, California woman reportedly suffered from liver failure after taking the weight lost/body building supplement. OxyElite Pro had been recalled by USPlabs Labs and has been removed from store shelves, according to NBC San Diego.
The Irish Health Chiefs (similar to the Surgeon General in the U.S.) also recently issued an alert over OxyElite Pro and Versa supplements and announced that the products are to be pulled from store shelves in that country, the Independent.ie reported. The Irish Medicines Board (IMB) and the Food Safety Authority Ireland (FSAI) said the involved products are OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, OxyElite Pro Super Thermo powder, and Versa-1.
In Ireland, The OxyElite and Versa-1 products have been associated to one case of liver injury, according to the Independent.ie.
According to a recent NBC San Diego report, more than 50 people have reported liver problems, including acute hepatitis and liver failure, after taking OxyElite Pro.
“We don’t really know what component in the product is responsible for the liver failure. There have been 56 cases reported to the CDC. There has been one death and two people have needed a liver transplant,” Dr. Eric McDonald, San Diego County Health and Human Services Agency’s Deputy Public Health Officer, told NBC San Diego.
We previously wrote that some people remain on the transplant waiting list for a liver.