With the product being sold online, several countries are warning their citizens of the risk of infant botulism.

The Ministry of Health has issued a public advisory regarding an international alert about contaminated ByHeart Whole Nutrition baby formula, which has been linked to multiple cases of infant botulism.

 According to the Centers for Disease Control

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is

November 14, 2025 

Press Release

Today, US Representative Rosa DeLauro released a letter she wrote to FDA Commissioner Marty Makary requesting the Food and Drug Administration facility inspection records for ByHeart, following reporting that the company’s infant formula was linked to an infant botulism outbreak:  

“There must never be a question in parents’ minds that

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is

The lawsuits filed Wednesday could be the first of many legal actions against ByHeart, said Bill Marler, a Seattle food safety lawyer who represents Dexter.

“This company potentially faces an existential crisis,” he said. 

The parents of at least two babies sickened in an infantile botulism outbreak are suing the makers of the ByHeart baby

One thing about preparing for a lawsuit is digging deep into the facts and the science. One of the recent refrains in this ByHeart infant formula Botulism Outbreak, is how could we have know? Well, you likely could have. Here are some abstracts of discussion of that risk.

Infant botulism is now the most common