Washington — U.S. health officials announced Friday that dozens of children have fallen ill from suspected food poisoning linked to contaminated infant formula produced by ByHeart.

The Food and Drug Administration (FDA) confirmed that tests detected bacteria capable of causing illness in two samples associated with the company’s formula. 

One unopened can of infant formula tested positive for the same strain found in a sick child, while contamination was also identified in samples of organic whole milk powder supplied to ByHeart and used in its production.

FDA investigators noted that the bacteria discovered in the raw milk powder matched contamination found in ByHeart’s finished product. However, the agency stressed that the findings are not yet conclusive and that the investigation remains ongoing “to determine the source of contamination.”

The incident has raised alarm among parents and health authorities, underscoring the vulnerability of infant nutrition supply chains and the importance of strict safety monitoring. Officials said further testing and coordination with the company are underway to ensure consumer protection and prevent additional cases.