CDPH: preliminary tests are Botulism positive in ByHeart Infant Formula

abdulmanannet77@gmail.comNovember 9, 2025

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CDPH: preliminary tests are Botulism positive in ByHeart Infant Formula

California alerted CDC to multi-state infant botulism outbreak linked to ByHeart infant formula

CDPH’s Infant Botulism Treatment and Prevention Program has seen 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 multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. Preliminary analyzes of a sample of the formula by the CDPH laboratory suggest the presence of the bacteria responsible for botulism. The company has recalled two batches of its products. Consumers owning this product should stop using it immediately.

SACRAMENTO– The California Infant Botulism Treatment and Prevention Program, which developed and provides the world’s only source of infant botulism treatment, has noted an increase in cases of infant botulism linked to ByHeart powdered infant formula. State public health officials subsequently alerted the U.S. Centers for Disease Control and Prevention (CDC) of a possible outbreak and are 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 (“To be used before December 1, 2026”)
Lot: 206VABP/251131P2 (“Use before December 1, 2026”)

According to the company’s website, ByHeart Whole Nutrition infant formula was sold on its ByHeart.com website and at 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 represents less than 1% of all infant formula sales in the United States and this outbreak is not creating infant formula shortage concerns for parents and caregivers.

Public health survey

CDPH tested a box of powdered infant formula that was given to an infant with infant botulism. Preliminary results suggest the presence of the bacteria that produces botulinum toxin, consistent with the same toxin reported in confirmed infant cases.

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. The affected infants had become ill starting in August 2025. Eight of these cases have since been confirmed to be toxin type A botulism, with testing underway for the remaining cases. Investigation into the numerous ByHeart powdered infant formulas 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 toxin-producing bacteria that cause infant botulism, leading to progressive muscle weakness, including difficulty breathing, if not treated in time.” saidDr. Erica Pan, CDPH Director and State Public Health Officer. “We have tested a sample of the specific powdered infant formula linked to these cases and preliminary tests are positive. We urge parents to immediately stop using ByHeart formula.”

Parents should immediately report any weakness, difficulty swallowing, or other signs of infant botulism in their infant to healthcare providers. Health care providers should immediately report suspected cases of infant botulism to their local health department to facilitate timely investigation, testing, and treatment, if indicated. If parents notice symptoms after an infant consumes formula, they should record the information on the package, including the brand and lot number, if still available. Do not throw away the product before checking with your local health department.

Typical signs and symptoms of infant botulism often begin with:

Constipation
Difficulty eating (sucking and swallowing)
Poor head control
A weak and altered cry
Decreased facial expression
Other signs of muscle weakness

What CDPH is doing to protect Californians

CDPH works closely with the CDC, FDA and other state health departments to identify and track cases of infant botulism, as well as to test suspected products 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, gaining FDA approval to produce this life-saving drug in 2003, and remains the world’s only source of BabyBIG. BabyBIG has been shown to reduce hospital length of stay and treatment costs for infants with botulism and remains the standard first-line treatment for infant botulism.

Physicians with a suspected case of infant botulism can contact the California Infant Botulism Treatment and Prevention Program at (510) 231-7600 at any time. Parents with concerns or questions regarding suspected infant botulism should seek medical attention immediately.

Infant botulism

Infant botulism is a form of botulism that occurs when swallowed spores of a particular bacteria (Clostridium botulinum) colonize a baby’s large intestine and produce botulinum toxin. Botulinum toxin causes weakness and loss of muscle tone because it blocks the ability of nerve endings to communicate with muscles. If left untreated, the disease can lead to respiratory failure and even death.

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