Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.
The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.
The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.
No deaths have been reported in the outbreak, which was announced Nov. 8.
Previously, health officials had stated the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August, when officials at California’s Infant Botulism Treatment and Prevention Program reported an increase in treatments for infants who had consumed ByHeart formula. With the expanded definition, the CDC identified 10 additional cases that occurred from December 2023 through July 2025.
ByHeart, a New York-based manufacturer founded in 2016, recalled all its products sold in the U.S. on Nov. 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling approximately 200,000 cans of the product each month.
News that ByHeart products could have been contaminated for years has distressed parents like Andi Galindo, whose 5-week-old daughter, Rowan, was hospitalized with botulism after drinking the formula. Galindo expressed concern that if the company had manufacturing issues since its inception, accountability is necessary.
Lab tests have detected contamination in samples from the company’s facilities, prompting increased scrutiny from the FDA.
Infant Botulism Explained
Infant botulism is a rare disease that affects fewer than 200 babies in the U.S. each year, typically developing after infants ingest botulism spores that germinate in their immature digestive systems. Symptoms may include poor feeding, constipation, and muscle weakness.
The sole treatment for this condition is known as BabyBIG, an IV medication derived from the blood plasma of adults vaccinated against botulism. Families that have sued ByHeart allege the formula was defective and that the company was negligent.
