The California Department of Public Health (CDPH) has alerted the U.S. Centers for Disease Control and Prevention (CDC) to an outbreak of infant botulism in several states linked to ByHeart Whole Nutrition infant formula. The alert prompted a nationwide recall and an ongoing investigation involving state and federal health agencies.
According to CDPH, the state’s Childhood Botulism Treatment and Prevention Program first noticed an unusual increase in cases earlier this year. Testing by the state public health laboratory found evidence of Clostridium botulinum, the bacteria that produces the toxin responsible for botulism, in a sample of ByHeart’s powder formula.
Health officials said 13 suspected or confirmed cases of infant botulism have been reported in 10 states since August. Eight of these cases have been confirmed as having type A food poisoning, while testing is continuing on the remaining cases.
ByHeart Inc. announced On November 8, it will recall two lots of complete infant formula: lot numbers 206VABP/251261P2 and 206VABP/251131P2, both of which carry a “use by December 1, 2026” date. The formula was sold online through ByHeart’s website and in major retail stores across the country, including Amazon, Target, Walmart, Whole Foods and Kroger.
“Infant botulism is a very rare illness that occurs when babies inhale or ingest toxin-producing bacteria spores,” Dr. Erica Pan, CDPH director and state public health officer, said in the department’s statement. “We have tested a sample of the infant formula powder associated with these cases and initial tests have come back positive. We urge parents to stop using ByHeart formula immediately.”
Symptoms of botulism in infants can include constipation, difficulty feeding, weak crying, poor head control, decreased facial expressions, and other signs of muscle weakness. In severe cases, the disease can lead to breathing problems if not treated immediately. Children with this condition require hospitalization but can make a full recovery with early diagnosis and medical care.
CDPH urges parents to immediately stop using the recalled product and contact their health care provider if their child shows any signs of illness. Parents should also keep any remaining formula packaging, including the batch number, for investigation purposes. Healthcare providers are required to report suspected cases to local health departments to ensure rapid testing and treatment.
Doctors treating potential cases can call the California Childhood Botulism Treatment and Prevention Program at (510) 231-7600 for assistance. Parents with concerns should seek medical care immediately.
According to the U.S. Food and Drug Administration (FDA), ByHeart Whole Nutrition infant formula represents less than 1% of the nation’s infant formula supply. The recall is not expected to affect the general availability of the formula to parents and caregivers, officials said. More information about the recall and ongoing investigation is available at California Department of Public Health and US Food and Drug Administration Websites.