As health officials investigate more than 30 cases of infant botulism linked to ByHeart baby formula since August, parents whose infants were sickened with the same illness prior to the current outbreak are demanding answers.
Confirming that six babies in California were treated for botulism related to ByHeart formula between November 2024 and June 2025, public health officials noted these cases predate the outbreak that has sickened at least 31 infants across 15 states.
Though officials indicated that earlier cases could not be immediately linked to a common source, parents of at least five babies reported their children were hospitalized for botulism after consuming ByHeart formula from late 2024 to early 2025, raising concerns over a potential continuous issue.
Amy Mazziotti recounted how her then-5-month-old son fell ill in March shortly after beginning to use ByHeart formula. Similarly, Katie Connolly shared that her daughter M.C. had to be hospitalized in April for the same illness linked to the formula.
In light of the initial dismissal of early cases, families expressed frustration over the investigation's focus narrowing only to later instances, questioning why their experiences weren't similarly acknowledged.
“What I want to know is why did the cases beginning in August flag an investigation, but the cases that began in March did not?” Connolly asks, expressing feelings of neglect regarding the safety of her child.
ByHeart has since recalled all its products nationwide, with laboratory tests confirming some of their formula samples were contaminated with bacteria linked to infant botulism. CDC officials are now working to address the unusually high surge in cases documented since August.
Experts highlight that with fewer than 200 cases of infant botulism reported in the U.S. annually, the potential connection to ByHeart formula poses a significant public health concern. Outside food safety experts stress that any earlier cases involving infected infants who consumed this formula should be considered part of the outbreak.
Connolly and Mazziotti report that their babies are on the mend but continue to face lingering health issues. With their lives changed irrevocably, these parents seek not only healing for their children but also clarity and accountability from ByHeart.



















