A baby formula made by a New York City company is under investigation after a botulism outbreak hospitalized 13 infants across ten states. The California Department of Public Health has urged consumers to stop using the product immediately. The recall affects two batches of ByHeart Whole Nutrition Infant Formula, according to an announcement last Saturday.
The botulism cases, affecting infants aged 2 weeks to 5 months, have been reported since mid-August across several states, including Arizona, California, Illinois, and Texas. Following state and federal investigations linking the product to the outbreak, ByHeart has recalled the formula with a best-by date of December 2026, NBC New York reports.
The connection between the formula and the illnesses emerged after California health officials reported preliminary test results from a can of the affected powdered formula. Although ByHeart stated that "more testing is needed," the situation remains urgent, as per NBC New York. The U.S. Food and Drug Administration is continuing its investigation and has been monitoring 83 cases of infant botulism since the outbreak began.
Infant botulism is a rare but serious condition, usually affecting fewer than 200 babies in the U.S. each year. It is often caused by environmental spores and can lead to severe symptoms, including paralysis. Dr. Steven Abrams, a nutrition expert at the University of Texas, told PBS News that such cases are "extremely rare." All affected infants have received treatment with BabyBIG, an antitoxin medication.
ByHeart, the company behind the formula, was founded in 2016 and accounts for about 1% of U.S. formula sales. So far, there is no sign of a wider impact on the national formula supply, unlike the shortages seen during the Abbott Nutrition crisis in 2021–2022. Health Secretary Robert F. Kennedy Jr. has launched an FDA review of infant formula ingredients to ensure the safety and nutritional quality of these essential products.
