Two more babies have been hospitalized amid an outbreak of botulism, a type of serious illness caused by botulinum toxin, federal health officials say.
As of Monday, a total of 15 babies were reported to have “suspected or confirmed” cases of infant botulism in 12 states, the U.S. Food and Drug Administration said in a statement. advisory published on Tuesday.
He the total includes two new cases from two new states, Kentucky and North Carolina, according to an update from the Centers for Disease Control and Prevention.
“In 14 cases with available disease onset information, the illnesses began on dates ranging from August 9 to November 10, 2025,” the FDA said in its notice. “All 15 children were hospitalized.”
Of the 14 babies with available information on age and sex, ages ranged from 16 days to just over 5 months, and half are girls, he added.
According to the notice, no deaths have been reported to date.
All of the babies who became ill were fed ByHeart Whole Nutrition powdered infant formula, the FDA said.
This undated image provided by ByHeart shows ByHeart formula products.
From the heart via AP
The multistate outbreak investigation is being conducted by the FDA and CDC, in collaboration with the California Department of Public Health’s Childhood Botulism Prevention and Treatment Program and other state and local health authorities, according to the notice.
memory announced for the first time a voluntary retirement of two batches of its comprehensive nutrition infant formula on November 8, “following notification of the [FDA] of a broader ongoing investigation into a recent outbreak of infant botulism.
On Tuesday, the the company said was expanding its previous recall includes all batches of its ByHeart Whole Nutrition infant formula cans and Anywhere Pack single-serve bars nationwide.
This image released by the FDA shows the ByHeart formula.
FDA
This image released by the FDA shows the ByHeart formula.
FDA
ByHeart said it was partnering with the FDA in expanding the recall “even though no unopened ByHeart products have tested positive for Clostridium botulinum spores or toxin.”
“The safety and well-being of every baby who uses our formula is, and always will be, our top priority,” ByHeart president and co-founder Mia Funt said in a statement. “This nationwide recall reflects our commitment to protecting babies and providing families with clear, actionable information. In addition to this recall, we are conducting comprehensive research to do our part and get the answers parents expect and deserve.”
The bacteria Clostridium botulinum can appear in food and produce the botulinum toxin that can cause botulism.
Botulism is a rare but serious disease. According to the Centers for Disease Control and PreventionBotulinum toxin can attack the nerves, causing difficulty breathing, muscle weakness and paralysis, visual disturbances, swallowing problems, speech problems, and even death.
infant botulism It occurs when a baby swallows Clostridium botulinum spores, which can then grow in the intestine and produce botulinum toxin, the agency states.
Symptoms of infant botulism may include poor diet, constipation, pupils that react slowly to light, drooping eyelids, fewer facial expressions than usual, low muscle tone, or a weaker than normal cry.
“Seek immediate medical attention if your baby has consumed ByHeart Whole Nutrition infant formula and has any of these symptoms,” the CDC states.
According to Tuesday’s FDA notice, information shared by the California Department of Public Health’s Infant Botulism Prevention and Treatment Program shows that as of August 1, 2025, “84 infants nationwide have received treatment for infant botulism.”
“Notably, more than 40% (15) of infants who were exposed to powdered infant formula consumed ByHeart Whole Nutrition infant formula,” the advisory states. “This data shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents approximately 1% of all infant formula sales in the United States.”
The agency said investigations into the outbreak are ongoing, but health officials have not yet identified “other brands of infant formula or shared exposures that pose a risk to infants.”
ByHeart has advised anyone who has cans of recalled ByHeart infant formula to stop using the product, throw it away and seek emergency help. medical care for any baby who may have any symptoms related to infant botulism.
Parents can contact the company by email at hello@byheart.com or by phone at (833) 429-4327.
