ByHeart Baby Formula Recall: Infant Botulism Outbreak Investigation and Treatment
An outbreak of botulism linked to ByHeart baby formula has affected at least 15 infants in 12 states, with nine confirmed cases of infant botulism type A. The outbreak, which began in mid-August, has prompted federal and state investigations. ByHeart, a New York-based organic baby formula maker, recalled two lots of its Whole Nutrition Infant Formula as a precautionary measure. Infants aged 2 weeks to 5 months have been hospitalized after consuming ByHeart powdered formula, leading to the recall of specific batches with best-by dates of December 2026.
California officials confirmed the presence of the toxin-producing bacteria in an open can of ByHeart baby formula fed to an affected infant. The outbreak has resulted in hospitalizations and treatment with BabyBIG, an IV medication used to combat botulism. Testing of unopened cans from the recalled batches is underway to provide clarity to concerned families. The FDA is investigating whether other cases of infant botulism in the U.S. are also linked to ByHeart formula.
Infant botulism is a rare condition caused by a toxin-producing bacterium that affects infants under 1 year old. Symptoms can include feeding difficulties, muscle weakness, and breathing problems. The only treatment available is BabyBIG, an expensive IV medication derived from adult blood plasma. ByHeart's recall of specific formula batches has not caused a shortage in the market, as the company represents a small percentage of national formula sales.
The ByHeart outbreak is distinct from previous formula-related crises, such as the Abbott Nutrition incident in late 2021 and 2022, which led to infant illnesses and deaths. ByHeart had previously recalled batches of formula due to contamination concerns. Federal health officials are reevaluating the safety of infant formula and working to enhance food supply regulations to prevent future outbreaks.