WASHINGTON D.C. — Federal health officials are investigating a multistate outbreak of infant botulism potentially linked to ByHeart Whole Nutrition infant formula. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are collaborating with state and local partners after epidemiologic and preliminary laboratory data suggested the infant formula might be contaminated with Clostridium botulinum.
As of November 10, 2025, a total of 15 infants from 12 states have been reported with suspected or confirmed infant botulism and confirmed exposure to ByHeart formula (various lots).
Key Details of the Investigation
- Illnesses Reported: The 15 infants were hospitalized, with illness onset dates ranging from August 9 to November 10, 2025. No deaths have been reported.
- Ages Affected: Affected infants range in age from 16 to 157 days.
- Disproportionate Representation: Out of 84 infants nationwide treated for botulism since August 1, 2025, over 40% (15) had consumed ByHeart formula. This is particularly concerning given that ByHeart represents an estimated 1% of all U.S. infant formula sales, indicating a disproportionate link.
- Preliminary Test Results: On November 8, 2025, the California Department of Public Health reported preliminary lab results suggesting the presence of $Clostridium botulinum$ in a can of ByHeart infant formula (Lot 206VABP/251131P2) fed to a sick infant. Additional testing is ongoing.
The FDA contacted ByHeart and requested an expansion of the recall. In response, on November 11, 2025, ByHeart expanded its recall to include all ByHeart formula nationwide, covering both cans and single-serve sticks.
Officials continue to investigate, but no other infant formula brands or shared exposures have been identified as posing a risk at this time. Caregivers are being interviewed to gather more information about the foods fed to the sick infants. The public health advisory will be updated as more information becomes available.
Infant botulism is a rare but serious condition caused by ingesting bacterial spores that produce a toxin in the baby’s intestines. Symptoms can include constipation, lethargy, poor feeding, and muscle weakness. Caregivers should contact a healthcare provider immediately if their infant exhibits these symptoms.
