ByHeart, Inc. has initiated a recall of specific lots of its Whole Nutrition Infant Formula following an outbreak of infant botulism affecting 13 infants across 10 states in the United States (AZ, CA, IL, MN, NJ, OR, PA, RI, TX, WA). The FDA and CDC are investigating the outbreak, which involves the pathogen botulinum toxin type A. No deaths have been reported.
The outbreak, identified between August and November 2025, has led to 13 hospitalizations. All affected infants reportedly consumed ByHeart's powdered formula, with cases confirmed in states such as Arizona, Illinois, and Washington. The formula is sold online and at major retailers nationwide. The FDA has recommended a voluntary recall due to the severity of the illnesses and the strong epidemiological link to the product.