FDA and CDC investigate multistate infant botulism cases tied to powdered infant formula; two lots recalled
Federal and state officials are investigating a multistate cluster of infant botulism illnesses after affected infants reportedly consumed ByHeart powdered formula. The company agreed to recall two lots as testing continues and more results are expected in coming weeks.
- Published
- Updated
Investigation spans 10 states as officials track a severe illness
The FDA and CDC, working with California public health authorities and other partners, are investigating a multistate outbreak of infant botulism illnesses involving 13 cases reported across 10 states. Officials said laboratory confirmation for some cases was ongoing, and no deaths had been reported at the time of the update.
The California Department of Public Health’s Infant Botulism Treatment and Prevention Program reported an increase in botulism type A infections among infants who had consumed ByHeart powdered infant formula between August 2025 and November 2025, prompting intensified epidemiological review and product testing.
Recall focuses on two lots while testing proceeds
According to the FDA, all 13 cases included in the outbreak were reported to have consumed ByHeart-brand powdered infant formula. State officials collected leftover product for testing, and federal authorities said results were expected in the coming weeks. In the meantime, the FDA recommended a voluntary recall based on the number of cases, severity of illness, and what it described as a strong epidemiological signal.
ByHeart, Inc. agreed to initiate a recall of two lots of its Whole Nutrition Infant formula: Lot 206VABP/251261P2 and Lot 206VABP/251131P2. The FDA said it would continue working with the firm to ensure potentially impacted product is removed from the market.
What parents and caregivers should do
Families concerned about exposure should check lot codes on product packaging and follow recall guidance from retailers and health agencies. Because infant botulism is a medical emergency, caregivers are urged to seek immediate medical attention for severe symptoms and consult pediatric clinicians for individualized advice about feeding and substitutions.
- Scope: 13 infant botulism illnesses reported across 10 states; no deaths reported at update time.
- Product: cases reported to have consumed ByHeart powdered infant formula; testing underway.
- Action: voluntary recall initiated for two lots (206VABP/251261P2 and 206VABP/251131P2).