A nationwide recall has been issued for all ByHeart Whole Nutrition Infant Formula products following a growing multistate outbreak of infant botulism. Federal health agencies, including the FDA and CDC, confirm that epidemiologic and early laboratory evidence points toward contamination of powdered ByHeart formula with Clostridium botulinum. The recall affects every lot of ByHeart formula cans and single-serve sticks sold across the United States in stores and online. Authorities warn parents and retailers to immediately remove and discontinue the use or sale of any ByHeart formula, as the investigation remains active and infant illnesses continue to be reported.
As of December 3, 2025, a total of 39 infants from 18 states have been hospitalized with suspected or confirmed infant botulism after consuming ByHeart powdered infant formula. Illness onset dates range from August 9 to November 19, and federal investigators are still receiving reports of recalled formula being sold at major retailers, including Walmart, Target, Kroger, Acme, and Shaw’s. This suggests ongoing recall lapses, raising concerns about continued consumer exposure.
Preliminary testing reported by ByHeart found that five out of 36 sampled products across three lots were positive for Clostridium botulinum Type A. Additional testing by FDA, CDC, and state laboratories is underway to determine the extent and point of contamination.
Infant botulism is a rare but severe illness caused when C. botulinum spores germinate and produce toxin inside a baby’s intestinal tract. Botulinum toxin is one of the most potent known biological toxins, capable of blocking nerve function and leading to muscle weakness, difficulty breathing, and, in severe cases, respiratory arrest. Unlike foodborne botulism in adults, which occurs from consuming preformed toxin, infants are especially vulnerable because their intestinal microbiome is still developing. Even a very small number of spores can lead to illness.
Infant botulism does not typically appear immediately after exposure. Instead, symptoms may develop gradually over days or even weeks. Affected infants often become unusually constipated, feed poorly, lose head control, and show reduced facial expressions. As the illness progresses, babies may develop overall body weakness, trouble swallowing, low energy, and breathing problems that require urgent medical support. Botulism can be life-threatening without prompt treatment.
Health officials are urging all parents and caregivers to stop using any ByHeart infant formula, regardless of the lot number. If an infant has consumed the formula and begins showing signs of illness, immediate medical care is essential. If no symptoms are present, continued monitoring is recommended. Parents should keep the product container after labeling it as “Do Not Use,” as state health departments may request it for testing if the child becomes ill. Containers can be discarded after 30 days if the infant remains symptom-free.
Parents with concerns can contact the California Department of Public Health hotline at 1-833-398-2022.
Retailers nationwide are expected to remove all ByHeart formula from shelves, including returned items. FDA has reiterated that recalled product should not be available for sale in any physical store or online platform. The recall includes all ByHeart formula cans and all single-serve “anywhere pack” sticks.
Federal and state agencies are continuing to trace supply chains, review production records, and analyze samples to determine how contamination occurred. Updates will be provided as testing and epidemiologic work progresses. The FDA emphasizes that this recall does not pose a risk of formula shortages, as ByHeart represents approximately 1 percent of the U.S. infant formula market.