State and local health departments warned over the weekend of a multistate outbreak of infant botulism linked to ByHeart formula.
The Los Angeles County and California departments of public health along with the U.S. Centers for Disease Control and Prevention are investigating possible contamination of ByHeart’s Whole Nutrition Infant Formula:
- Lot No. 206VABP/251261P2 with “Use by 01 Dec 2026” printed on the bottom of the powdered formula canister and
- Lot No. 206VABP/251131P2 with “Use by 01 Dec 2026.”
The company recalled the two lots of the product Saturday.
California’s Infant Botulism Treatment and Prevention Program, which officials said provides the only source of infant botulism treatment in the world, noted an increase in cases linked to ByHeart formula and alerted the federal CDC of a possible outbreak.
Officials reported 13 suspected or confirmed cases of ByHeart-connected infant botulism in 10 states. Preliminary testing of one sample of the formula by the state botulism program’s 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,” CDPH Director and State Public Health Officer Dr. Erica Pan said in a 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.”
According to ByHeart Inc., Whole Nutrition Infant Formula was sold through the the company’s website and via national retail operations including Amazon, Kroger, Walmart, Whole Foods, Target and SamsClub.com.
ByHeart Whole Nutrition Infant Formula makes up less than 1% of all infant formula sales in the U.S., so the outbreak is likely not to cause an infant formula shortage, according to the FDA.
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.
Los Angeles County health officials advised parents or caregivers to seek immediate medical care if an infant shows any of these symptoms: constipation, difficulty feeding, sucking or swallowing, weak cry or diminished facial expression, poor head control and muscle weakness or trouble breathing.
Currently, one confirmed case is in LA County, according to Public Health. The infant was hospitalized and is now recovering.
Parents seeking guidance or who are concerned about possible botulism exposure should contact their physician. Information is also available from the Public Health InfoLine, 833-540-0473 daily from 8 a.m. to 8 p.m.
