Fifteen infants in 12 states have been hospitalized since August in a rare outbreak of infant botulism that federal health officials say is disproportionately linked to ByHeart Whole Nutrition powdered infant formula. The US Food and Drug Administration, working with the Centers for Disease Control and Prevention and state agencies, has urged parents and caregivers to stop using any ByHeart formula immediately after preliminary testing by the California Department of Public Health suggested the presence of bacteria capable of producing the botulinum toxin.
The recall began November 8 with two lots of ByHeart formula and was expanded just days later to include all unexpired cans and single‑serve “anywhere” sticks nationwide. “The safety and well‑being of every infant who uses our formula is, and always will be, our highest priority,” said ByHeart president and co-founder Mia Funt. “This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information.”
Infant botulism is an uncommon illness- fewer than 200 cases occur in infants in the US each year-but it could be deadly. It develops when spores of Clostridium botulinum -often found in dust, soil, or certain foods-colonize a baby’s intestines and begin producing toxin inside the body. Because the gut microbiomes of infants are not mature enough to suppress harmful bacteria, babies under six months are particularly vulnerable. Symptoms can take weeks to appear and may include constipation, poor eating, loss of head control, drooping eyelids, reduced facial expression, and muscle weakness that can progress to breathing difficulties.
All affected infants in the current outbreak have received BabyBIG®, the only available antitoxin for infant botulism, which was developed by California’s Infant Botulism Treatment and Prevention Program. The medicine has been shown to reduce the length of hospital stays and the severity of illness, but many babies nonetheless require ventilators and weeks of supportive care. The FDA reports that, despite ByHeart formula accounting for only about 1 percent of formula sales in the US, more than 40% of infants with powdered formula exposure in this outbreak consumed ByHeart formula.
While large in scope, this recall will not result in a national shortage, officials emphasize. That contrasts with the 2022 Abbott Nutrition crisis, in which contamination concerns and plant closures led to months‑long supply disruptions that forced some families to adopt unsafe feeding practices. Experience from the crisis has resulted in more effective recall policies, better lot number tracing in hospitals, and increased oversight by the FDA, including the establishment of the Office of Critical Foods for supply chain protection.
The ByHeart inquiry is part of a wider effort by federal health agencies to enhance formula safety. Under “Operation Stork Speed,” the FDA has launched its first comprehensive review of infant formula nutrients since 1998, increased testing for heavy metals and contaminants, and encouraged greater transparency in labeling. “Every child has a fundamental right to a healthy start,” said Health Secretary Robert F. Kennedy Jr. “We’re giving parents the truth and the tools to make that happen.”
For the time being, health officials suggest parents monitor any infant who consumed the ByHeart formula for signs of botulism, get immediate care if symptoms develop, and retain their formula containers for possible testing. Even without symptoms, vigilance is important botulism can be fatal if it is not treated, but early intervention greatly improves outcomes.
