OxyElite Issues Recall Following Liver Illness Outbreak
Last Updated on January 11, 2022
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At A Glance
- This Alert Affects
- Individuals who took certain dietary supplements labeled OxyElite Pro.
- Damages
- Acute hepatitis, liver failure/damage, acute liver failure, liver transplant, hospitalization or death.
- Company(ies)
- USPlabs LLC
- Additional Details
- Fever, fatigue, nausea, loss of appetite, vomiting, abdominal pain, dark urine, clay-colored bowel movements, joint pain, yellow eyes, and jaundice may be early signs of liver damage or failure in acute hepatitis patients.
- Date
- On November 9, 2013, the FDA announced that USPlabs would be voluntarily recalling several OxyElite products after reports of a dangerous link between liver injuries and the dietary supplement surfaced in Hawaii.
- Type of Lawsuit
- Mass Tort
On November 9, 2013, the dietary supplement manufacturer USPlabs LLC voluntarily issued a recall for all lots and sizes of the following OxyElite Pro products:
- OxyElite Pro Super Thermo capsules
- OxyElite Pro Ultra-Intense Thermo capsules
- OxyElite Pro Super Thermo Powder
The Hawaii Department of Health (HDH) was the first to notice a trend in otherwise healthy patients developing hepatitis, which can result in liver damage or failure. Of the 46 health records the HDH sent to the FDA for analysis, more than half of the reported liver illnesses occurred in patients who used OxyElite Pro products. Although USPlabs maintains that its products are safe, they decided to take the supplement off the market “out of an abundance of caution,” according to a news report from CNN.
The attorneys who work with our website believe those who were injured by OxyElite Pro may be able to take legal action against USPlabs LLC. If you believe you were harmed by an OxyElite dietary supplement, you may be eligible for compensation. Please fill out our free case review form on the right for more information.
OxyElite Banned for Use
OxyElite was banned for use after the FDA asked the manufacturer to stop distributing the supplements. The agency discovered that OxyElite Pro supplements contain an ingredient called aegeline, a compound not previously present in the food supply. Such “new dietary ingredients” must meet specific standards before being used in dietary products to establish that they are safe for consumption. After discovering that aegeline may “present a significant or unreasonable risk of illness or injury,” the FDA mailed a warning letter to USPlabs ordering the manufacturer to cease all distribution of the supplements immediately. If USPlabs failed to cease distribution, the FDA warned that they would discontinue any distribution by way of law.
Liver Damage, Failure, and Hepatitis Linked to OxyElite
The dangers reportedly associated with OxyElite Pro include acute hepatitis, liver damage, liver failure, and acute liver failure, which may result in hospitalization, liver transplant, or death.
Days before the OxyElite recall, the Hawaii Department of Health submitted 46 medical records to the FDA indicating 27 patients developed liver damage or failure after consuming OxyElite Pro products. Seventeen of these patients claimed that OxyElite Pro was the only supplement they were taking.
Additional cases of liver damage been reported in a number of other states, according to a health alert from the FDA. The FDA, the Center for Disease Control and Prevention, and local health officials have since launched an investigation into a total of 56 cases of acute non-viral hepatitis. More than 20 of these patients have been hospitalized, two have gotten liver transplants, and one has died.
Should I File an OxyElite Lawsuit?
The FDA is warning consumers not to use any dietary supplements labeled OxyElite Pro, and those who suspect they may have been injured by the product should contact their doctor.
The lawyers who work with our website have reason to believe that USPlabs’ OxyElite Pro is harmful, and the manufacturer may soon be facing legal action over the alleged injuries caused by its dietary supplements.
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