The California Department of Public Health is working with counterparts in other states and the U.S. Centers for Disease Control and Prevention to investigate a multi-state outbreak of infant botulism linked to a certain brand of infant formula that recalled two lots of the product.
So far, there are 13 suspected or confirmed infant botulism cases linked to ByHeart powdered infant formula in 10 states, according to California health officials. Preliminary testing of one sample of the formula by the CDPH laboratory suggests the presence of the bacterium that causes botulism.
“Infant Botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time,” said CDPH Director and State Public Health Officer Dr. Erica Pan. “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.”
According to the ByHeart Inc. website, Whole Nutrition Infant Formula was sold through the website and through retail operations nationwide including
Amazon, Kroger, Walmart, Whole Foods, Target and SamsClub.com.
ByHeart Inc. on Saturday recalled two lots of its Whole Nutrition Infant Formula, Lot 206VABP/251261P2 and Lot 206VABP/251131P2, both with a use
by date of Dec. 1, 2026.
ByHeart Whole Nutrition Infant Formula makes up less than 1% of all infant formula sales in the U.S., according to the Food and Drug Administration, so this outbreak does not create infant formula shortage concerns for parents and caregivers.
Parents who notice botulism symptoms after their infant consumed formula should record the brand and lot number and should not discard the package until they check with their local health department. Healthcare providers should report suspected cases of infant botulism to local health officials.
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