Families Sue ByHeart Over Recalled Formula Linked to Infant Illnesses

On November 13, 2025, the parents of two infants sickened by infantile botulism have filed lawsuits against the makers of ByHeart baby formula. The outbreak, which began in August, has affected at least 15 infants across a dozen states, though no deaths have been reported.

The Dexter family of Flagstaff, Arizona, said their 4-month-old daughter Rose had to be airlifted to a children's hospital and treated for several weeks. Similarly, the Everett family of Richmond, Kentucky, rushed their 4-month-old daughter Piper to the hospital on November 8 as her symptoms worsened. Both babies received the sole treatment available, an IV medication called BabyBIG.

The lawsuits allege the ByHeart formula the babies consumed was defective and that the company was negligent in selling it. The families say they chose the organic formula, believing it to be a natural, healthier alternative. ByHeart has recalled all of its formula nationwide, and California officials confirmed a sample contained the type of bacteria that can lead to botulism.

The legal actions could be the first of many against ByHeart, which a food safety lawyer says "potentially faces an existential crisis." The company says it remains focused on ensuring families are aware of the recall and have accurate information.