California alerts CDC to multi-state outbreak of infant botulism linked to ByHeart infant formula
CDPH's Child Botulism Treatment and Prevention Program has noted an increase in cases and launched a national investigation
What you need to know: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 multi-state outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. Preliminary testing of one sample of the mixture by the CDPH laboratory suggests the presence of the bacteria that causes botulism. The company has recalled two batches of its products. Consumers using this product should stop using it immediately.
SACRAMENTO– The California Infant Botulism Treatment and Prevention Program, which has developed and provides the world's only source of treatment for infant botulism, has noted an increase in cases of infant botulism associated with the use of ByHeart powdered infant formula. State public health officials then alerted the U.S. Centers for Disease Control and Prevention (CDC) to the possible outbreak and are working with other state health departments and the CDC to investigate a multi-state outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. Consumers who have this product should stop using it immediately.
November 8, 2025 ByHeart Inc. has recalled two lots of Whole Nutrition infant formula:
- Lot: 206VABP/251261P2 (“Use until December 1, 2026”)
- Lot: 206VABP/251131P2 (“Use until December 1, 2026”)
According to the company's website, ByHeart Whole Nutrition infant formula was sold through their website, ByHeart.com, and through retail stores nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, SamsClub.com and others. According toUS Food and Drug Administration (FDA)ByHeart Whole Nutrition's infant formulas account for less than 1 percent of all infant formula sales in the United States, and this outbreak is not creating formula shortage issues for parents and caregivers.
Public Health Investigation
CDPH tested a can of powdered infant formula that was fed to an infant with infant botulism. Preliminary results suggest the presence of botulinum toxin-producing bacteria, consistent with the same toxin reported in confirmed cases in infants.
The CDC, CDPH and other state health departments are investigating 13 suspected or confirmed cases of infant botulism linked to ByHeart powdered infant formula in 10 states. Affected infants became ill starting in August 2025. Since then, eight of those cases have been confirmed to be toxin botulism type A, and the remaining cases are awaiting testing. The investigation into the large quantities of ByHeart powdered infant formula and potential sources of botulism in infants is ongoing.
What parents of babies need to know
“Infant botulism is a very rare disease that occurs when children inhale or ingest spores of the toxin-producing bacteria that cause infant botulism, leading to progressive muscle weakness, including breathing problems, if not treated promptly.” saidDr. Erica Pan, CDPH Director and State Health Officer. “We have tested a sample of the specific infant formula associated with these cases and preliminary tests are positive. We urge parents to immediately stop using ByHeart formula.”
Parents should immediately report to health care providers any weakness, difficulty swallowing, or other signs of infant botulism in their children. Health care providers should immediately report suspected infant botulism to their local health department to facilitate investigation, testing, and prompt treatment if indicated. If parents notice symptoms after their baby has consumed formula, they should write down the information on the package, including the brand and lot number if still available. Do not throw away the product before consulting your local health department.
Typical signs and symptoms of infant botulism often begin with:
- Constipation
- Difficulty feeding (sucking and swallowing).
- Poor head control.
- Weak and altered cry
- Reduced facial expression
- Other signs of muscle weakness
What CDPH is doing to protect Californians
CDPH is working closely with the CDC, FDA and other state health departments to identify and track cases of infant botulism and to test the suspected product in California at the state public health laboratory.
BabyBIG Antitoxin is the only FDA-approved treatment for infant botulism. CDPH led the development of BabyBIG in the 1990s, receiving FDA approval for the life-saving drug in 2003, and remains the only source of BabyBIG in the world. BabyBIG has been shown to reduce hospital length of stay and treatment costs for children with botulism and remains the standard first-line treatment for infant botulism.
Physicians who suspect infant botulism can contact the California Infant Botulism Treatment and Prevention Program at (510) 231-7600 at any time. Parents who have concerns or questions about suspected infant botulism should seek medical attention immediately.
Infant botulism
Infant botulism is a form of botulism that occurs when ingested spores of a certain bacterium (Clostridium botulinum) colonize the baby's colon and produce botulinum toxin in it. Botulinum toxin causes weakness and loss of muscle tone because it blocks the ability of nerve endings to communicate with muscles. If left untreated, this disease can lead to respiratory failure and even death.
Resources for more information:
