Two additional infants have been hospitalized due to an outbreak of botulism, a serious illness caused by the botulinum toxin, according to federal health officials. As of Monday, the U.S. Food and Drug Administration reported a total of 15 infants with suspected or confirmed cases of infant botulism across 12 states. This includes new cases from Kentucky and North Carolina, as noted in an update from the Centers for Disease Control and Prevention.

The FDA's advisory indicated that for 14 of the cases with available illness onset information, symptoms began between August 9 and November 10, 2025. All 15 infants have been hospitalized. Among the 14 infants for whom age and sex data is available, ages range from 16 days to just over 5 months, with half being female. No fatalities have been reported so far.

The infants affected were all fed ByHeart Whole Nutrition powdered infant formula. The FDA and CDC are conducting a multistate outbreak investigation in collaboration with the California Department of Public Health's Infant Botulism Treatment and Prevention Program, along with other state and local health authorities.

ByHeart initially announced a voluntary recall of two batches of its Whole Nutrition Infant Formula on November 8, following notification from the FDA about a broader investigation into the outbreak. On Tuesday, the company expanded its recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack single-serve sticks nationwide. ByHeart stated it is working with the FDA on this recall expansion, despite no unopened products testing positive for Clostridium botulinum spores or toxin.

Mia Funt, president and co-founder of ByHeart, emphasized the company's commitment to safety, stating, "The safety and well-being of every infant who uses our formula is, and always will be, our highest priority. This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve."

Clostridium botulinum bacteria can be found in food and produce the botulinum toxin, which can lead to botulism, a rare but serious illness. The CDC notes that the toxin can affect the nervous system, causing symptoms such as difficulty breathing, muscle weakness, paralysis, visual disturbances, trouble swallowing, speech issues, and potentially death. Infant botulism occurs when a baby ingests Clostridium botulinum spores, which can grow in the gut and produce the toxin.

Symptoms of infant botulism may include poor feeding, constipation, slow-reacting pupils, drooping eyelids, reduced facial expressions, low muscle tone, or a weaker-than-normal cry. The CDC advises seeking immediate medical attention if an infant has consumed ByHeart Whole Nutrition Infant Formula and exhibits any of these symptoms.

According to the FDA's advisory, data from the California Department of Public Health indicates that since August 1, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, over 40% of these infants (15) had exposure to ByHeart Whole Nutrition infant formula. This suggests that ByHeart formula is disproportionately represented among sick infants in this outbreak, especially considering it accounts for an estimated 1% of all infant formula sales in the U.S.

Investigations into the outbreak are ongoing, and health officials have not yet identified other infant formula brands or shared exposures that may pose a risk to infants. ByHeart has advised consumers to stop using any recalled products and to seek immediate medical care for infants showing symptoms of botulism. Parents can reach the company via email or by phone for further assistance.