The company that makes OxyElite Pro, the dietary supplement linked to recent severe cases of hepatitis, has finally recalled certain shipments that appear to be associated with one reported death and at least 56 illnesses among customers using the product.

The company, USPLabs, had previously stopped shipments of the weight-loss product, but initiated a recall on Nov. 10 after the U.S. Food and Drug Administration threatened using legal action to stop distribution and sales.

Health investigators are still not sure why the supplement seems to have caused illnesses of hepatitis in dozens of people and the death of a 48 year-old woman from Hawaii on Oct. 9, just weeks after she had taken the supplement.

The Hawaii State Department of Health is spearheading an investigation into the issue. It could be caused by an ingredient, a contaminant, or a product production error, said Hawaii State Epidemiologist Dr. Sarah Park. They just don’t know yet.

That majority of known cases have been found in Hawaii, and Park told Food Safety News the state may be a canary in the coal mine in the sense that other states could possibly not be fully aware of the problem.

At least 44 people in Hawaii are believed to be connected to the outbreak. Of those, 36 used OxyElite Pro. According to Park, a handful of others took similar brand-name products, but there’s no other product coming up even close to the same frequency.

Hepatitis is a liver disease, with symptoms that include fatigue, fever, nausea, jaundice and diarrhea.

The Aloha State may be especially sensitive to detecting severe hepatitis outbreaks because only one hospital in the state can handle acute liver failure and transplants. That hospital also happens to be across the street from the state health department, Park said.

When doctors at the hospital suddenly started receiving young and middle-aged adults with liver failure, they knew they had a problem on their hands.

“They looked for infections, cancer, all sorts of other things,” Park said. “They couldn’t find any particular reason for these people to have liver injuries other than the fact that they all took OxyElite Pro as a dietary supplement.”

That evidence was too strong to ignore, Park said.

“This is hit-you-over-the-head hepatitis,” she added.

According to FDA, at least 12 other people in 12 other states have been connected to the outbreak since the end of October.

Hawaii health officials worry there are more hepatitis cases on the mainland that haven’t been connected to the outbreak. Hepatitis is not typically an illness that clinicians report to health departments, especially if they are not aware of a larger problem, Park said.

The Hawaii victims also received products from a variety of means, including from local stores, various online retailers and directly from the manufacturer’s website, suggesting little reason for the problem to disproportionately affect Hawaii.

The products involved in the recall include:

  • OxyElite Pro Super Thermo capsules
    –two count capsules UPC #094922417275
    –10 count capsules UPC #094922417251
    –10 count capsules UPC #094922417268
    –21 count capsules UPC #094922426604
    –90 count capsules UPC #094922395573
    –90 count capsules “Pink label” UPC #094922447906
    –180 count capsules UPC #094922447852
  • OxyElite Pro Ultra-Intense Thermo capsules
    –three count capsules UPC #094922447883
    –three count capsules UPC #094922447876
    –90 count capsules UPC #094922395627
    –180 count capsules UPC #094922447869
  • OxyElite Pro Super Thermo Powder
    –Fruit Punch 0.15 oz UPC #094922417237
    –Fruit Punch 0.15 oz UPC #094922447517
    –Fruit Punch 4.6 oz UPC #094922426369
    –Fruit Punch 5 oz. UPC #094922447487
    –Blue Raspberry 4.6 oz UPC #094922426376
    –Grape Bubblegum 4.6 oz UPC #094922447500
    –Green Apple 4.6 oz. UPC #094922426499