Infant formula recalled after botulism outbreak reported in cases across U.S.

The California Department of Public Health (CDPH) has alerted the U.S. Centers for Disease Control and Prevention (CDC) to a multistate outbreak of infant botulism connected to ByHeart Whole Nutrition Infant Formula. The alert has prompted a nationwide recall and an ongoing investigation involving state and federal health agencies.

According to CDPH, the state’s Infant Botulism Treatment and Prevention Program first noticed an unusual increase in cases earlier this year. Testing by the state’s public health laboratory found evidence of Clostridium botulinum, the bacteria that produce the toxin responsible for botulism, in a sample of ByHeart powdered formula.

Health officials said 13 suspected or confirmed cases of infant botulism have been reported across 10 states since August. Eight of those cases have been confirmed as type A botulism, while testing continues on the remaining cases.

ByHeart Inc. announced on Nov. 8, that it was recalling two lots of its Whole Nutrition Infant Formula: lot numbers 206VABP/251261P2 and 206VABP/251131P2, both marked with a “Use by 01 Dec 2026” date. The formula was sold online through ByHeart’s website and in major retail stores nationwide, including Amazon, Target, Walmart, Whole Foods, and Kroger.

“Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria,” said Dr. Erica Pan, CDPH Director and State Public Health Officer, in the department’s statement. “We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately.”

Symptoms of infant botulism can include constipation, difficulty feeding, a weak cry, poor head control, reduced facial expression, and other signs of muscle weakness. In severe cases, the illness can lead to breathing problems if not treated promptly. Babies with the condition require hospitalization but can recover fully with early diagnosis and medical care.

The CDPH is urging parents to immediately stop using the recalled product and contact a healthcare provider if their child shows any signs of illness. Parents should also keep any remaining formula packaging, including the lot number, for investigation purposes. Healthcare providers are asked to report suspected cases to local health departments to ensure rapid testing and treatment.

Physicians treating possible cases can contact California’s Infant Botulism Treatment and Prevention Program at (510) 231-7600 for assistance. Parents with concerns should seek medical attention right away.

According to the U.S. Food and Drug Administration (FDA), ByHeart Whole Nutrition Infant Formula accounts for less than 1% of the nation’s infant formula supply. Officials said the recall is not expected to impact overall availability of formula for parents and caregivers.More information about the recall and ongoing investigation is available on the California Department of Public Health and U.S. Food and Drug Administration websites.