ByHeart Baby Formula Linked to Botulism Outbreak: Urgent Recall Issued

Mon Nov 10 2025 02:03:17 GMT+0200 (Eastern European Standard Time)

California health officials have linked ByHeart's baby formula to a botulism outbreak affecting 13 infants across 10 states. A recall has been issued as investigations continue.

California’s health authorities have announced that the ByHeart Whole Nutrition Infant Formula is associated with an unusual botulism outbreak that has sickened at least 13 infants. Officials urge anyone with the affected formula to stop using it immediately while further investigations are ongoing. Authorities are testing the product to confirm the presence of the harmful bacteria and are working to examine the formula's ingredients as the FDA initiates reviews of infant products.

Preliminary tests showed that ByHeart baby formula contained the type of bacteria that produces the toxin linked to a botulism outbreak, according to California health officials.

The outbreak has affected at least 13 infants in 10 states, with no reported fatalities.

“Consumers in possession of this product should stop using it immediately,” the California Department of Public Health stated late Saturday.

Investigations by state and federal health officials are ongoing into ByHeart Whole Nutrition Infant Formula, which was recalled over two lots identified. This investigation stems from incidents that started in mid-August.

Understanding the Botulism Outbreak

The affected infants, aged from 2 weeks to 5 months, require hospitalization after consuming the ByHeart powdered formula, as reported by the Centers for Disease Control and Prevention (CDC).

The cases were reported across states such as Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

ByHeart’s Whole Nutrition Infant Formula has a best-by date of December 2026, as confirmed by the FDA.

Moreover, California health officials tested a can of the formula consumed by a baby who became ill, which suggested the presence of the bacteria producing the botulism toxin. Results confirming these findings are still pending.

ByHeart has acknowledged the potential presence of harmful bacteria and is committed to further testing. They reaffirmed their seriousness regarding the situation in a statement.

The FDA is reviewing reports of 83 cases of infant botulism since August, including those linked to ByHeart baby formula.

Causes and Treatments

Infant botulism affects fewer than 200 babies annually across the U.S. It stems from bacteria that produce toxins in the intestines, primarily endangering infants under one year, who may contract it from various environments or contaminated foods such as honey.

Signs include poor feeding, drooping eyelids, and difficulty swallowing or breathing. Currently, treatments involve hospital-administered medication known as BabyBIG, developed specifically for treating infant botulism.

Future Implications

This situation presents no threat to national infant formula supplies, with ByHeart holding an estimated 1% of the market share. The formula's recall is not expected to replicate the severe shortages seen after the Abbott product crisis in 2022.

Authorities have pledged to reassess the standards and ingredients across infant formula products as part of an initiative dubbed “Operation Stork Speed,” marking the first thorough review in decades.