Archive · 20 Nov 2025
Infant Botulism Cases Rise in US Amid ByHeart Formula Recall
Some babies in the US got very sick from a type of germ called botulism in a specific brand of baby formula called ByHeart.
The company and the FDA are working to make sure no more babies get sick, but some of the formula that was supposed to be taken off the shelves is still being found in stores.
ByHeart recalled two lots of its infant formula due to potential botulism risk
31 infants have been hospitalized with suspected or confirmed botulism since August
Recalled formula still found on store shelves, FDA warns against using ByHeart formula
FDA Commissioner emphasizes swift action to prevent further illnesses
ByHeart accounts for about 1% of US formula sales
- Who
- Infants in the US, ByHeart company, FDA
- What
- Infant botulism cases linked to recalled ByHeart formula
- When
- Since August 2023
- Where
- 15 US states
- Why
- Contamination of ByHeart formula with bacteria that can cause botulism
ByHeart Company
FDA
Recall and Investigation
ByHeart Company
ByHeart recalled the formula and is investigating the source of contamination
FDA
FDA is working with ByHeart to handle the recall and prevent further illnesses
- Recalled Formula
- Two lots of ByHeart infant formula
- Number of Hospitalizations
- 31 infants
- States Affected
- 15
- ByHeart Market Share
- About 1% of US formula sales
- FDA Warning
- Do not use any ByHeart formula products