California Alerted CDC of Multistate Infant Botulism Outbreak Linked to ByHeart Infant Formula

SACRAMENTO, CA, Nov 8 – 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 infant botulism cases linked to ByHeart powdered infant formula. State public health officials then alerted the U.S. Centers for Disease Control and Prevention (CDC) of a possible outbreak and is working with other state health departments and the CDC to investigate a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. Consumers in possession of this product should stop using it immediately.

On November 8, 2025, ByHeart Inc. recalled two lots of 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, 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 to the U.S. Food and Drug Administration (FDA), ByHeart Whole Nutrition Infant Formula makes up less than 1 percent of all infant formula sales in the United States and this outbreak does not create infant formula shortage concerns for parents and caregivers.

Public Health Investigation
CDPH has tested a can of powdered infant formula that was fed to an infant with infant botulism. Preliminary results suggest the presence of the bacteria that produce botulinum toxin, consistent with the same toxin reported in the confirmed infant cases.

CDC, CDPH, 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 had become ill starting in August 2025. Eight of those cases have since been confirmed as toxin type A botulism, with tests pending for the other cases. The investigation into lots of ByHeart powdered infant formula and potential sources of botulism in infants is ongoing.

What Parents of Infants Need to Know
“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, CDPH 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 should report any weakness, difficulty swallowing, or other signs of infant botulism in their infants to healthcare providers immediately. Healthcare providers should report suspected cases of infant botulism to their local health department immediately to facilitate investigation, testing and timely treatment if indicated. If parents note symptoms after an infant has consumed formula, they should record the information on the package including brand and lot number, if still available. Do not discard the product prior checking with your local health department. Typical signs and symptoms of Infant botulism often begin with:

• Constipation
• Difficulty feeding (sucking and swallowing)
• Poor head control
• A weak and altered cry
• Diminished 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, as well as test suspected product in California at the state’s public health lab.

The antitoxin BabyBIG is the only FDA-approved treatment for infant botulism. CDPH led the development of BabyBIG in the 1990’s, 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.

Physicians with a suspected case of infant botulism may reach California’s Infant Botulism Treatment and Prevention Program at (510) 231-7600 at any time. Parents with concerns or questions about suspected infant botulism should seek medical advice immediately.

Infant Botulism
Infant botulism is the form of botulism which 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.