- Infant formula maker ByHeart has recalled all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack sticks due to an outbreak of infantile botulism linked to the company’s products. ByHeart initiated the recall of two batches of formula on November 8, 2025, after it was notified of approximately 13 reported cases of botulism in infants that had consumed its products throughout the U.S. The company expanded the recall three days later after an additional 10 cases were reported.
- California officials reported that a sample taken from an open can of ByHeart formula contained Clostridium botulinum, which leads to botulism infection. According to ByHeart, no previously unopened product has tested positive for the bacteria. In addition to recalling product, the company is conducting testing of every batch of formula through a third-party laboratory and providing FDA and the California Department of Public Health access to its facilities and unopened product for testing.
- The families of at least two babies who were treated for botulism have sued ByHeart, alleging the company negligently sold defective formula that they purchased because they viewed it “as a natural, healthier alternative to traditional baby formulas.” The families are seeking payment for medical bills, emotional distress, and other harm.
- Illnesses linked to ByHeart formula began between August 9 and November 11 and were reported in 13 states. Investigators have not identified any other infant formula brands or other sources of exposure in the outbreak.
- Keller and Heckman will continue to monitor and report on this and other foodborne illness outbreaks.