Federal health officials on Wednesday expanded an outbreak of infant botulism connected to recalled ByHeart baby formula to encompass all reported illnesses since the company began production in March 2022.
The U.S. Food and Drug Administration stated that investigators cannot rule out the possibility that contamination might have affected all ByHeart formula products ever made.
Currently, the outbreak includes at least 51 infants from 19 states. The updated case definition now includes any infant with botulism who had exposure to ByHeart formula at any time since the product’s release, according to the U.S. Centers for Disease Control and Prevention. The latest reported illness occurred on December 1.
Fortunately, no fatalities have been linked to this outbreak that first came to light on November 8.
Previously, health officials reported 39 suspected or confirmed cases of infant botulism in 18 states since August, following increased treatment of affected infants. With the expanded definition, the CDC has identified 10 additional cases occurring from December 2023 to July 2025.
ByHeart, a New York-based manufacturer of organic infant formula established in 2016, recalled all its products sold in the U.S. on November 11. The company was distributing about 200,000 cans of product each month, which constitutes approximately 1% of the U.S. infant formula market.
News regarding the potential for prolonged contamination struck a chord with parents like Andi Galindo, whose 5-week-old daughter was hospitalized with infant botulism after consuming the formula. Galindo had opted for ByHeart based on a lactation consultant's recommendation.
“If there is proof that there were issues with their manufacturing from the start, that is concerning and they need to be held accountable,” Galindo expressed.
Testing by an independent laboratory previously indicated that 36 samples from various lots contained hazardous bacteria. Health officials revealed that ByHeart had a history of contamination issues, including a recall in 2022 following a positive test for cronobacter sakazakii.
Infant botulism is a rare but serious condition affecting fewer than 200 babies in the U.S. annually, primarily due to immature gut microbiomes. Despite previous sporadic links to baby formula, no known outbreaks have been confirmed through powdered formula before this incident.
Families have begun filing lawsuits against ByHeart alleging negligence, seeking damages for medical expenses and emotional distress.
