ByHeart Baby Formula Linked to Botulism Cases in 10 States

Preliminary tests have revealed the presence of bacteria responsible for producing the botulism toxin in ByHeart baby formula, prompting health officials in California to issue an urgent warning. The bacterium is linked to an outbreak that has affected at least 13 infants across 10 states. Fortunately, no fatalities have been reported. The California Department of Public Health strongly advised consumers to discontinue use of the product immediately.

The investigation into the outbreak began in mid-August when several cases of infant botulism were reported, all involving babies aged between 2 weeks and 5 months who had consumed the powdered formula. According to the U.S. Centers for Disease Control and Prevention (CDC), affected states include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

In response to the situation, ByHeart, the New York-based manufacturer, has voluntarily recalled two lots of its Whole Nutrition Infant Formula, which has a best-by date of December 2026. The recall was initiated following tests conducted on a can of formula that was fed to an infant who later fell ill. These tests “suggest the presence” of the bacteria associated with botulism, which has been confirmed in other affected cases. Further testing is currently underway to validate these findings.

The outbreak has raised significant concern as the FDA is investigating a total of 83 reported cases of infant botulism since August, including those specifically linked to ByHeart’s product. While this type of botulism typically affects fewer than 200 babies annually in the U.S., it can lead to severe health complications, including paralysis.

Infant botulism is primarily caused by a specific type of bacteria that produces toxins in the large intestine. The spores can be present in the environment, and infants are particularly vulnerable due to their immature digestive systems. Symptoms may take weeks to manifest and can include poor feeding, loss of head control, drooping eyelids, and a flaccid appearance.

Treatment for botulism in infants primarily involves a medication called BabyBIG, which is derived from the blood plasma of adults who have been immunized against the toxin. Developed by California’s Infant Botulism Treatment and Prevention Program, BabyBIG is the only treatment available worldwide and effectively reduces the severity of illness and shortens hospital stays. All infants affected in the current outbreak have received this treatment.

Despite the serious nature of the outbreak, experts have noted that there is no immediate risk of a nationwide shortage of infant formula due to ByHeart’s limited market share, which accounts for approximately 1% of total U.S. sales. This situation contrasts sharply with the 2022 crisis involving Abbott Laboratories, which resulted in widespread shortages following contamination issues that were linked to severe illnesses and fatalities among infants.

In light of this incident, federal health officials have committed to reviewing the safety and nutritional standards of infant formula in the U.S. Health Secretary Robert F. Kennedy Jr. has instructed the Food and Drug Administration (FDA) to conduct a comprehensive assessment of ingredients in infant formula, marking the first thorough review since 1998. This initiative, called “Operation Stork Speed,” aims to enhance the safety of products consumed by millions of American infants.

The situation remains under close scrutiny as health officials continue their investigation and testing efforts to ensure the safety of infant formula products across the country.