OxyElite Pro RecallOxyElite Pro, one of the most popular diet and weight-loss supplements, has been withdrawn from the market twice and re-formulated due to concern about unsafe ingredients. The first withdrawal involved DMAA, a controversial stimulant linked to cardiovascular side effects. The second withdrawal involved dozens of reports of liver damage in Hawaii from May until October 2013.

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OxyElite Pro Recall

November 10, 2013 — USPLabs, LLC, the manufacturer of OxyElite Pro, has agreed to voluntarily recall OxyElite Pro after the FDA threatened to use its authority to force a recall. Evidence linking OxyElite Pro and liver injuries has been growing for months — the first cases occurred in at least as early as May 2013, and the first warnings were issued in September. Even so, USPLabs aggressively defended the safety of OxyElite Pro. 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

The FDA warns that evidence supports a “causal connection” between OxyElite Pro and liver damage, including liver failure:

“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?

OxyElite Pro was withdrawn from the market in October 2013, soon after the Hawaii Department of Health (DOH) reported an unusual cluster of liver injuries. The initial cluster involved 7 reports of acute non-viral hepatitis (liver inflammation) linked to dietary supplements. By October 8, liver injuries were reported in 29 people, 24 of whom reported using OxyElite Pro. At least 11 people have been hospitalized, 2 people have required liver transplants, and 1 woman has died.

The FDA and the Centers for Disease Control (CDC) each issued updates and announced they would begin an investigation into liver injuries linked to dietary supplements in the mainland United States.

In the meantime, USPLabs, the manufacturer of OxyElite Pro, has agreed to stop distributing the products (specifically, “OxyElite Pro with the Purple Top” and “OxyElite Pro Super Thermo Powder“). They caution that counterfeit OxyElite Pro has been sold in the United States for “some time,” and they have defended the safety of their products:

“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?

OxyElite Pro was previously withdrawn from the market after a controversial ingredient, DMAA, was linked to cardiovascular side effects. The FDA warned:

“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.”

In April 2012, the FDA sent a Warning Letter to USPLabs and 10 other manufacturers of DMAA-containing supplements, recommending that they “immediately cease distribution of your products.”

While most of these other manufacturers re-formulated their products or discontinued them, USPLabs attempted to convince the FDA that DMAA was a natural botanical derived from the geranium plant, and not a synthetic “designer drug.” They were not successful. The FDA ordered U.S. marshals to seize 3,200 cases of the product. In July 2013, the FDA announced that USPLabs reportedly destroyed $8 million worth of Jack3D and OxyElite Pro.

Need an OxyElite Pro Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

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The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact our Texas OxyElite Pro lawyers for a free lawsuit review.