Manufacturer confirms CDPH’s identification of Clostridium botulinum through independent testing in ByHeart powdered infant formula
What You Need to Know: California Department of Public Health Director and State Public Health Officer Dr. Erica Pan issued the following statement on the third-party confirmation of CDPH’s identification of Clostridium botulinum – the bacterial spores that cause infant botulism – in ByHeart powdered infant formula.
SACRAMENTO – California Department of Public Health Director and State Public Health Officer Dr. Erica Pan issued the following statement on the third-party confirmation of CDPH’s identification of Clostridium botulinum – the bacterial spores that cause infant botulism – in ByHeart powdered infant formula.
“I’m incredibly proud of the public health investigation led by our Infant Botulism Treatment and Prevention Program and the Microbial Diseases Laboratory. Their dedication to sound science and disease investigation identified ByHeart infant formula as the common thread in this outbreak and led directly to the prevention of more cases across the country. We also deeply appreciate the work of our partners at the federal level and across multiple states in containing this outbreak.
This investigation highlights the critical importance of public health and the role it plays in protecting the public in situations such as this. California’s commitment to protecting our communities from disease and other public health emergencies requires resources and the dedication of talented and compassionate individuals. I cannot express how thankful I am to our staff for their commitment to our mission and for their work in identifying this outbreak. Many dedicated staff have been working long hours, seven days a week on this outbreak. Together, they have helped prevent further cases of infant botulism across the country.”
The Infant Botulism Investigation
CDPH’s Infant Botulism Treatment and Prevention Program first noticed an increase in requests for BabyBIG, the only FDA-approved anti-toxin for infant botulism, in infants with common product exposure and alerted federal partners at the Centers for Disease Control and Prevention and the US Food and Drug Administration. The ensuing investigation identified ByHeart powdered infant formula as a common possible source of exposure.
CDPH led the development of BabyBIG in the 1990s, securing FDA approval to produce the life-saving drug in 2003, and remains the only source of BabyBIG in the world. BabyBIG has been shown to reduce the length of hospital stays and treatment costs for infants with botulism and remains the standard first-line therapy for infant botulism.
Rapid testing by CDPH found Clostridium botulinum, which causes infant botulism, in an opened container of ByHeart infant formula that had been fed to an infant diagnosed with the disease, and a national Do Not Use recommendation was issued by California, the CDC, and the FDA. A recall was also initiated by ByHeart, at first for just two lots and after additional cases emerged, expanded to all ByHeart products.
Subsequent testing by an independent third-party testing lab contracted by ByHeart then found Clostridium botulinum in multiple sealed containers of ByHeart infant formula.
California’s Botulism Hotline
As part of its emergency response, California established a public hotline, open seven days a week from 7 a.m. to 8 p.m. PST to answer questions from concerned parents and caregivers about infant botulism. Trained public health staff continue to be available to provide answers and information to concerned members of the public with questions about the outbreak. CDPH’s medical staffing line for health care providers and other clinical and case consultation continues to operate 24/7.
CDPH Public Infant Botulism Call Line
1-833-398-2022
Monday – Sunday, 7 a.m. – 8 p.m. PST
Infant Botulism
Infant botulism is the form of botulism that results when swallowed spores of a particular bacterium (Clostridium botulinum) colonize a baby’s large intestine and produce botulinum toxin in it. Botulinum toxin causes weakness and loss of muscle tone because it blocks the nerve ending’s ability to communicate with muscles. If left untreated, the condition can lead to respiratory failure and even death.
Additional Resources
- CDPH’s Infant Botulism Treatment and Prevention Program (IBTPP)
- FDA’s Outbreak Investigation of Infant Botulism: Infant Formula (Nov. 2025)
- CDC’s Infant Botulism Outbreak Linked to Infant Formula, Nov. 2025
