A dietary supplement has been linked to a cluster of lead poisoning cases in the Chicago area, according to the Food and Drug Administration. The FDA found that it contains 56 times more lead than the amount known to pose a health risk in children.

The supplement, called “DHZC-2” (shown below) is sold under the Life Rising/Ton Shen Health brand. A company representative declined to say what the supplement is used for, saying it’s “too complicated to explain,” but an FDA spokesperson said the company claims that the product can help “regulate blood circulation."

Chicago’s Cook County Department of Health reported that two children believed to have taken the drug had elevated lead levels in their bodies. And two adults died after taking the supplement, though the FDA says it is not yet certain whether the supplement contributed to those deaths.

“This is so dangerous because supplements can lead to extremely serious health consequences,” says Pieter Cohen, M.D., an assistant professor of medicine at Harvard Medical School and an expert on adulterated dietary supplements. “Sometimes, even death.”

Supplements are not as carefully regulated as prescription or over-the-counter medications. And because there is little vetting of the products before they arrive on store shelves, people sometimes have to get sick before the FDA knows there’s a problem, Cohen says. “The only way these dangerous supplements are withdrawn is if astute physicians or consumers contact the FDA directly,” he says.  

Lead exposure, especially in high doses, can wreak havoc on nearly every organ in the body, according to the FDA. It can cause abdominal pain, behavior or mood changes, coma, delirium, irritability, lethargy, seizures, vomiting, and weakness. But lead poisoning is especially dangerous for children, as it can cause developmental delays, learning disabilities, and lowered IQ.

Ton Shen Health, which recalled a limited number of lots of the DHZC-2 tablets on August 11, expanded it on August 25 to include all lots of the tablets. That includes all packaging marked with the UPC code 616042102727. But the FDA says, for now at least, consumers should avoid all Life Rising products.