Two families are suing infant formula manufacturer ByHeart after their babies developed infantile botulism, a rare and potentially life-threatening illness they allege was caused by the company’s recently recalled formula.
“I wouldn’t guess that a product designed for a helpless, developing human in the United States could cause something this severe,” said Stephen Dexter, 44, whose 4-month-old daughter Rose was airlifted to Phoenix Children’s Hospital after consuming the formula that was later recalled.
A Growing Outbreak
The infant botulism outbreak linked to ByHeart formula began in August 2025 and has sickened at least 15 infants across a dozen states. Federal health officials report that 84 infants nationwide have been treated for infantile botulism since August, though thankfully no deaths have been reported.
ByHeart initiated a voluntary recall on November 7, 2025, pulling two batches of its Whole Nutrition Infant Formula from shelves after the FDA notified the company of the outbreak. Among the affected infants, 13 had reportedly consumed ByHeart formula.
For the Dexter family of Flagstaff, Arizona, the recall came too late. Their daughter Rose had already fallen ill after consuming the formula, prompting an emergency medical airlift to Phoenix. Similarly, Michael and Hanna Everett of Richmond, Kentucky, watched their 4-month-old daughter Piper’s condition deteriorate after feeding her the same brand.
“It’s supposed to be similar to breast milk,” said Hanna Everett, explaining why they had chosen the premium formula for their daughter.
What Is Infant Botulism?
Infant botulism occurs when babies ingest Clostridium botulinum spores that germinate in their immature intestinal tracts. The bacteria then produce a potent neurotoxin that can cause progressive muscle weakness, starting with symptoms like constipation and feeding difficulties.
The condition primarily affects infants under six months old, and its effects can be devastating. Medical experts note that it may take up to 30 days for signs of infection to appear after exposure.
Both Rose Dexter and Piper Everett received the only treatment available for infant botulism: an IV medication called BabyBIG, which is derived from the blood plasma of people immunized against botulinum neurotoxins. Piper has since shown improvement following the treatment.
Legal Action and Company Response
The Dexter and Everett families have filed lawsuits in federal courts in two states, alleging the formula was defective and that ByHeart was negligent. Their suits seek financial compensation for medical costs, emotional distress, and other harms.
What makes this case particularly troubling for parents? The premium formula, which sells approximately 200,000 cans monthly nationwide, is marketed as a high-quality alternative specifically designed for infant nutrition.
“I’m a little concerned with things that are in food that may cause problems. We do our best to buy something that says it’s organic,” said Stephen Dexter, highlighting the trust parents place in formula manufacturers to provide safe products for their most vulnerable family members.
The consequences for ByHeart could be severe. “This company potentially faces an existential crisis,” said Bill Marler, the food safety lawyer representing Stephen Dexter, suggesting the legal and reputational fallout could threaten the company’s very survival.
As investigations continue and more families come forward, this outbreak serves as a stark reminder of the fragility of our food safety systems, especially when it comes to products designed for the most vulnerable among us.
