It was publicly announced that on November 8th, 2025, a multistate outbreak of infant botulism had been brought to the surface by the consumption of ByHeart Whole Nutrition Infant Formula. The company subsequently initiated a voluntary recall of two lots of formula.
On November 11th, 2025, the recall expanded to all lots and all product formats, including even cans and single-serve “Anywhere Packs,” after new cases kept rising.
The company resumed testing 36 samples from three lots and found five of those cases positive for spores of Clostridium botulinum Type A, the bacterium that is known to be both responsible for and the source of botulism. ByHeart further stated that they “cannot rule out the risk of contamination in all ByHeart formula across all product lots.”
On November 19th, 2025, the company reported 31 infants across 15 U.S. states as confirmed or suspected cases of infant botulism, leading to their hospitalization. By November 26th, 2025, the number of affected infants had risen to 37 cases, spanning across 17 U.S. states with no deaths reported. The recall proceeded to be issued nationwide, urging consumers to stop usage immediately even if cans appear completely normal.
ByHeart and government agencies are carrying out a full-scale supply chain audit, including additional product testing and a detailed review of manufacturing processes and ingredient sourcing. Previous safety inspections of the manufacturing facility reportedly identified breaches, including hygiene violations, raising concerns about the company’s manufacturing practices.
Henceforth a common question asked by citizens could be, ‘What is infant botulism, and what are the symptoms one should be aware of?’
Infant botulism occurs when an infant ingests or consumes spores of C. botulinum. While the gut flora of an infant remains fragile and immature, these spores can germinate in them and produce potent neurotoxins, which can cause serious harm, discomfort, and illness to the newborn babies.
While constipation and difficulty in being fed and swallowing are the most primarily seen symptoms, weak or altered cries, loss of head control, poor muscle tone, generalized weakness, or, in the severe cases, respiratory difficulties are able to be seen. In regard to the severity, all cases have required hospitalized treatment thus far.
The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have been leading a multistate outbreak investigation, alongside state health agencies and the specialized treatment program run by the California Department of Public Health (CDPH)’s Infant Botulism Treatment and Prevention Program (IBTPP). After making a public statement of its “full cooperation,” ByHeart has made a commitment to refund consumers who purchased product from its website (on or after August 1st, 2025) and has resumed removing all product from retail distribution.
As a precaution, ByHeart formula should be stopped being used immediately; any surfaces, bottles, or feeding equipment that came into contact with the formula should be thoroughly cleaned using hot, soapy water or a dishwasher; the lot number and “use by” date should be documented before discarding or returning; infants should be monitored for symptoms; and if contacted, the FDA should be notified right away.
Health departments and medical professionals across multiple states have been alerted to monitor for infants showing symptoms of botulism and to take any history of formula exposure into account during evaluation.
The outbreak highlights gaps in powdered infant formula regulation and microbial testing, alarming experts about spore-forming bacteria in baby products.
The incident has triggered calls for stricter safety standards, mandatory testing for C. botulinum spores, and improved manufacturing oversight, aiming to prevent future outbreaks and ensure the safety of infant formula for newborns nationwide.
