A dietary supplement may be responsible for a string non-viral hepatitis cases that led to a death, two liver transplants, and 11 hospitalizations.
A common link found between a number of the cases was use of a dietary supplement called OxyElite Pro, which is distributed by USPLabs LLC of Texas, Reuters reported.
Overall, there have been 29 cases of the dangerous condition in Hawaii and 24 had been taking some form of the supplement.
An investigation is underway to see if the condition was caused by OxyElite Pro or a counterfeit version of the supplement.
"The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues. Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner," the U.S. Food and Drug Administration (FDA) said in a statement.
Non-viral hepatitis can cause "fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice," the FDA reported.
The condition is not contagious, and is often associated with alcoholism, drugs, and excessive use of prescription medication or over-the-counter pills like Tylenol, Reuters reported.
USPLabs said it ""stands by the safety of all of its products," and "the cluster of liver issues in Hawaii is a complete mystery," Reuters reported.
The company will cease distribution of its product for now "out of an abundance of caution."
Investigators are analyzing Hawaii medical records and product samples of OxyElite to find out the cause of the fatal outbreak.
"In the interest of protecting public health, we are moving quickly to learn as much as possible," the FDA said, Reuters reported. "We recognize that people will be concerned about these illnesses, and we will provide updates as the investigation develops