An OxyElite Pro recall has been issued in Hawaii after 29 cases of acute hepatitis and liver failure were linked to the controversial workout supplement in October 2013. The Hawaii Department of Health (DOH) and U.S. Food & Drug Administration (FDA) are warning the public to stop using OxyElite, and the manufacturer has voluntarily agreed to suspend production and distribution of the product until the investigation can be completed. Of the 29 hepatitis and liver failure cases reported in Hawaii, 11 patients required emergency hospitalization, two received liver transplants, and a 48-year-old woman died from her injuries.
OxyElite Pro Recall 11/10/13: USPlabs has announced a recall for all lots and sizes of OxyElite Pro after the supplement was linked to a nationwide outbreak of acute hepatitis and liver failure. The U.S. Food & Drug Administration (FDA) is investigating at least 36 cases of the diseases that have been associated with OxyElite Pro over the past six months.
Click here to learn more. Free OxyElite Pro Recall Lawsuit Evaluation: If you or a loved one developed liver damage, liver failure, or hepatitis after taking OxyElite Pro, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Why was the OxyElite Pro Recall Issued?
According to the Hawaii Department of Health (DOH), at least 24 out of 29 patients under investigation reported taking OxyElite Pro prior to sustaining their injuries. All cases of acute hepatitis and liver failure associated with the supplement occurred from May to October 2013. According to the CDC, the median age of the patients is 33, and 14 are male. At least 2 of the patients were forced to undergo liver transplant surgeries. Eleven required emergency hospitalization, and 2 remain hospitalized. One patient, 48-year-old Sonnette Marras, died after using OxyElite Pro to lose weight gained during pregnancy. The 48-year-old Maui resident had seven children, ranging in age from 1 to 26.
Hepatitis / Liver Failure Symptoms
Signs and symptoms of OxyElite Pro-induced acute hepatitis or liver failure may include:
- loss of appetite
- abdominal pain
- dark urine
- clay or gray-colored bowel movements
- joint pain
- jaundice (yellowish eyes and/or skin)
Counterfeit OxyElite Pro Suspected in Hepatitis / Liver Failure Cases
The FDA stated that it is currently investigating whether counterfeit versions of OxyElite Pro were related to any of the hepatitis or liver failure cases in Hawaii. Counterfeit products are believe to be widely-circulated throughout the state and around the country. USPlabs, the company that manufactures OxyElite Pro, issued a press release stating “the cluster of liver issues in Hawaii is a complete mystery” and that all the company’s products are safe to use. In 2012, the FDA issued a warning to companies who sold products that contained a controversial substance known as 1,3-dimethylamylamine (DMAA), urging them to recall their supplements immediately or reformulate them without the ingredient. USPlabs was issued this letter because two of its products, OxyElite Pro and Jack3d, were known to contain DMAA. The FDA is still attempting to determine whether the OxyElite Pro linked to the hepatitis and liver damage cases in Hawaii was the older, DMAA-containing variety or the new formulation. USPlabs said OxyElite Pro hasn’t been sold with DMAA since early 2013, and that distribution of the newer version has been halted until the investigation is over.
FDA Recommendation on OxyElite Pro
The FDA has advised consumers to stop taking OxyElite Pro until the investigation into the hepatitis and liver failure cases can be completed. If you believe you may have been injured by OxyElite Pro, you should consult your doctor immediately. For information about how to file an OxyElite Pro Recall Lawsuit, fill out the confidential contact form below or call (866) 588-0600 to speak with one of our representatives.
Additional Resources and Information
- Hawaii State Department of Health - Hawaii Department of Health OxyElite Pro Weight Loss Supplement Pill Liver Failure Hepatitis Outbreak
- U.S. Food & Drug Administration (FDA) - OxyElite Pro: Health Advisory – Acute Hepatitis Illness Cases Lined to Product Use
Do I Have an OxyElite Pro Recall Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in OxyElite Pro recall lawsuits. We are handling individual litigation nationwide and currently accepting new OxyElite Pro recall cases in all 50 states. Free OxyElite Pro Recall Lawsuit Evaluation: Again, if you or a loved one developed liver damage, liver failure, or hepatitis after taking OxyElite Pro, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.