California reports infant botulism outbreak linked to formula
ByHeart recall affects two formula lots sold nationwide
– The California Department of Public Health is working with other state health departments and the U.S. Centers for Disease Control and Prevention to investigate a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula.
California’s Infant Botulism Treatment and Prevention Program, which developed and provides the only source of infant botulism treatment in the world, noted an increase in cases associated with ByHeart powdered infant formula. State officials alerted the CDC of a possible outbreak. Preliminary testing of a sample by the California Department of Public Health laboratory suggests the presence of the bacterium that causes botulism.
On Nov. 8, ByHeart Inc. recalled two lots of its Whole Nutrition Infant Formula:
- Lot 206VABP/251261P2 (“Use by 01 Dec 2026”)
- Lot 206VABP/251131P2 (“Use by 01 Dec 2026”)
According to the company’s website, the product was sold through ByHeart.com and in retail stores nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, and SamsClub.com. The U.S. Food and Drug Administration reported that ByHeart Whole Nutrition Infant Formula accounts for less than 1 percent of U.S. infant formula sales and said the outbreak does not pose a formula shortage risk.
The California Department of Public Health tested a can of powdered infant formula fed to a baby with infant botulism. Preliminary results indicated the presence of bacteria that produce botulinum toxin, consistent with the toxin detected in confirmed infant cases.
The CDC, California Department of Public Health, and other state health departments are investigating 13 suspected or confirmed infant botulism cases linked to ByHeart powdered infant formula across 10 states. The affected infants became ill starting in August. Eight cases have been confirmed as toxin type A botulism, with testing pending for others. The investigation into the contaminated lots and potential sources of exposure is ongoing.
“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 Dr. Erica Pan, California Department of Public Health Director and State Public Health Officer. “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.”
Parents are urged to report any weakness, difficulty swallowing, or other signs of infant botulism to healthcare providers right away. Providers should notify local health departments immediately to enable investigation, testing, and timely treatment. Parents should retain packaging, record the brand and lot number, and avoid discarding the product until consulting with their local health department.
Typical symptoms of infant botulism include constipation, difficulty feeding, poor head control, weak or altered cry, diminished facial expression, and other signs of muscle weakness.
The California Department of Public Health is collaborating with the CDC, FDA, and other states to track cases and test suspected formula at the state laboratory.
The department’s Infant Botulism Treatment and Prevention Program developed BabyBIG, the only FDA-approved treatment for infant botulism. Created in the 1990s and approved in 2003, BabyBIG is produced exclusively by the state and remains the global standard therapy, reducing hospital stays and treatment costs.
Physicians treating suspected infant botulism cases may contact the Infant Botulism Treatment and Prevention Program at (510) 231-7600. Parents with concerns should seek medical attention immediately.
Infant botulism occurs when spores of Clostridium botulinum colonize a baby’s intestine and produce botulinum toxin, which causes weakness and loss of muscle tone by blocking nerve communication with muscles. Untreated cases can lead to respiratory failure and death.
