California health officials say they have identified cases of infant botulism with exposure to powdered infant formula that occurred prior to the current multistate outbreak.
In a statement, a spokesperson for the California Department of Public Health (CDPH) said the state has identified at least six cases of infant botulism with exposure to ByHeart powdered infant formula that occurred from November 2024 to June 2025. The 15-state outbreak currently being investigated by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), which includes four sickened infants in California and 31 nationwide, began on August 1, 2015.
"CDPH is continuing investigate, but at this time we cannot connect any pre-August 1 cases to the current outbreak," the CDPH spokesperson said.
The statement explained that in early 2025 there was not enough evidence to immediately suspect a common source among the six suspected cases, and that the number of cases were within expected case numbers based on previous years' trends.
CPDH has played a critical role in investigation
Infant botulism occurs when a baby swallows Clostridium botulinum spores, which can grow in the intestine and produce toxins that cause constipation, poor feeding, loss of head control, and difficulty swallowing.
CDPH's detection of C botulinum in an opened can of ByHeart Whole Nutrition Infant Formula on November 8 led the FDA to recommend a recall of the product. Prior to the outbreak investigation, no powdered infant formula had tested positive for C botulinim in the United States.
CDPH said that, from August 1 through November 19, 107 infants nationwide have received treatment with BabyBIG, a human plasma-derived treatment for infants with botulism. That includes confirmed cases and infants who were being treated while awaiting test results.
CPDH developed and is the only source of BabyBIG. The CDC and FDA began their investigation into the outbreak after officials with CPDH's Infant Botulism Treatment and Prevention Program alerted them to an increase in requests for the treatment.