In 2013, the diet and weight-loss supplement OxyElite Pro was taken off the market twice over concern about dangerous ingredients. Under pressure from the FDA, USPLabs took OxyElite Pro off the market in early 2013 to remove a controversial ingredient called DMAA. In October, the company voluntarily stopped manufacturing and selling OxyElite Pro pending an investigation into at least 29 liver injuries in Hawaii.
What You Can Do & How an OxyElite Pro Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting dietary supplement induced injury cases in all 50 states. If you or somebody you know was injured by OxyElite Pro, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
OxyElite Pro Recall
November 10, 2013 — After the U.S. Food and Drug Administration (FDA) threatened to force a recall of OxyElite Pro, USPLabs LLC has agreed to a voluntary recall. The recall has come several months after health officials first linked OxyElite Pro to liver injuries. Cases were identified in May 2013 in Hawaii, and health officials issued a warning in September. Even so, USPLabs continued to defend the safety of OxyElite Pro, even as the FDA and Centers for Disease Control (CDC) warned that evidence supported a “causal connection” between OxyElite Pro and liver damage. Click here to read more.
Products included in the OxyElite Pro Recall:
- OxyElite Pro Super Thermo Capsules
- OxyElite Pro Super Termo Powder
- OxyElite Pro Ultra-Intense Capsules
According to the OxyElite Pro recall announcement:
“In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.”
Why was the OxyElite Pro recall issued?
In October 2013, USPLabs announced that they would cease domestic distribution of OxyElite Pro. The announcement came shortly after 29 liver injuries linked to dietary supplements were reported to the Hawaii State Department of Health (DOH), including 24 people who used OxyElite Pro within the last 60 days. All of the liver injuries occurred very rapidly, and nearly half (11 out of 29) were hospitalized. Liver failure occurred in 2 people, and a 48 year-old mother of 7 died.
The Centers for Disease Control (CDC) and the U.S. Food and Drug Administration (FDA) have been forced to recall furloughed employees to investigate liver injuries in other states. They are also investigating whether counterfeit OxyElite Pro is being distributed throughout the United States.
USPLabs defends the safety of their product:
“The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market. We know of no credible evidence linking OxyELITE Pro to liver issues.”
When was OxyElite Pro with DMAA recalled?
USPLabs first withdrew OxyElite Pro from the market in early 2013 to remove DMAA, a moderate stimulant drug. The controversial ingredient was listed as “geranium” on the label. According to the FDA, its potent side effects include:
“DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack.”
The FDA began taking DMAA off the market in April 2012, when they issued Warning Letters to USPLabs. The FDA warned that “synthetically produced dimethylamylamine is not a dietary ingredient” and told them to “immediately cease distribution of your products.”
At the time, OxyElite Pro was one of the best-selling weight-loss supplements. For months, USPLabs tried to convince the FDA that DMAA was not a synthetic “designer drug,” but rather a natural botanical extract of the geranium plant.
OxyElite Pro with DMAA remained on the market, available over the internet and in stores like Vitamin Shoppe and GNC, until early 2013. In July 2013, more than a year after the FDA began enforcement, the agency announced the seizure of 3,200 cases of the product and announced USPLabs destroyed OxyElite Pro and Jack3D with a retail value of $8 million.
Do I have an OxyElite Pro Lawsuit?
The Schmidt Firm, PLLC is currently accepting dietary supplement induced injury cases in all 50 states. If you or somebody you know was injured by OxyElite Pro, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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