FDA expands ByHeart infant botulism outbreak
The FDA and CDC broadened the infant botulism outbreak tied to ByHeart formula to include any case since the brand’s March 2022 launch, bringing the total to at least 51 infants across 19 states, with the most recent illness on Dec. 1, 2025. ByHeart recalled all U.S. products on Nov. 11 and FDA inspectors visited plants in Iowa and Oregon; an independent lab found Clostridium botulinum in 36 samples from three lots, and FDA says it cannot rule out contamination across all products.
📌 Key Facts
- Scope: At least 51 infant cases in 19 states; definition now covers exposures since March 2022.
- Recall: ByHeart recalled all U.S. products on Nov. 11; company sold ~200,000 cans per month.
- Inspections/Testing: FDA inspected Iowa and Oregon facilities; independent lab reported 36 positive samples from 3 lots; no deaths reported.
📊 Relevant Data
In 2021, there were 181 reported cases of infant botulism in the United States.
Approximately 100 cases of infantile botulism are reported annually in the United States, with around 20% linked to raw honey consumption.
Infantile Botulism - StatPearls — NCBI Bookshelf - NIH
Powdered infant formula is not sterile and can sometimes have germs such as Cronobacter.
In 2022, an outbreak of Cronobacter infections was linked to powdered infant formula, resulting in four reported cases, including two deaths.
Cronobacter Outbreak Linked to Powdered Infant Formula — CDC