The Massachusetts Department of Public Health (DPH) is alerting providers to a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. As of November 10, 2025, 15 cases have been reported in 12 states. ByHeart Whole Nutrition infant formula is a powdered product that has been distributed widely including by large national retail stores and online distributors and has now been voluntarily recalled by the manufacturer.
DPH recommends that providers maintain heightened vigilance for infants presenting with findings compatible with infant botulism who may have consumed ByHeart formula. Please contact DPH 24/7 at 617-983-6800 immediately for consultation regarding testing and treatment if botulism is suspected. Treatment with BabyBIG antitoxin can be lifesaving and should be initiated based on clinical criteria prior to the availability of test results.
Massachusetts Department of Public Health