Contaminated milk powder likely source of ByHeart baby formula botulism outbreak: FDA
Powdered whole milk used to make ByHeart infant formula could be a source of contamination that led to an outbreak of botulism that has sickened dozens of babies, according to US health officials.
Testing by the US Food and Drug Administration (FDA) found the type of bacteria that could cause the illness in two samples linked to the formula, officials said on Friday.
The agency found that bacteria in an unopened tin of formula matched a sample from a sick baby. It also matched contamination detected in samples of organic whole milk powder used to make ByHeart formula and collected and tested by the company.
FDA testing also found contamination in a sample of whole milk powder supplied to ByHeart – and it matched the germ in a finished sample of the company’s formula.
The findings were not conclusive, and the investigation continued “to determine the source of the contamination”, the agency said in a statement.
A ByHeart official said the finding helped shed light on what has become a “watershed moment” for the company.