Botulism Outbreak Linked to ByHeart Formula Affects 51 Infants

A significant outbreak of infant botulism has been linked to ByHeart baby formula, affecting 51 infants across 19 states in the United States. The Food and Drug Administration (FDA) reported that all affected infants were hospitalized, with cases beginning as early as August 9, 2023. No fatalities have been reported to date, but the situation has raised serious concerns about the safety of the product.

On December 10, 2023, the FDA confirmed that the outbreak has expanded from a previous count of 39 cases reported earlier in the month. The increase includes additional cases that occurred between December 2023 and July 2025 due to an expanded definition of the outbreak. The states reporting illnesses include Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin, with Ohio being the latest addition.

The FDA has indicated that all ByHeart infant formula products have been recalled and should not be available for sale. This recall applies to all formula cans and single-serve “anywhere pack” sticks. Despite this, reports from consumers suggest that ByHeart products were still found on store shelves at major retailers, including Walmart, Target, and Kroger, as recently as December 3, 2023.

California health officials confirmed that a sample from an open can of the ByHeart formula fed to an infant who became ill contained the botulism-causing bacteria. The tests involved injecting mice with the cultured bacterium and monitoring them for symptoms, which, according to Dr. Erica Pan, the state health officer, showed rapid illness onset.

The Centers for Disease Control and Prevention (CDC) has emphasized that botulism is a rare but serious disease that can lead to paralysis and death. Symptoms usually manifest weeks after exposure and may include poor feeding, loss of head control, and difficulty swallowing. The only available treatment, known as BabyBIG, is an intravenous medication derived from the pooled blood plasma of adults immunized against botulism. The cost of treatment is notably high, with vials priced at approximately $69,300 each.

In response to the outbreak, ByHeart officials have urged parents and caregivers to immediately discontinue use of the affected formula and dispose of any remaining products. The company stated that they are conducting thorough testing in collaboration with the FDA and CDC, and they are committed to ensuring the safety of their products.

The infant botulism outbreak has affected babies aged between 2 weeks and 5 months. This condition typically leads to fewer than 200 cases annually in the U.S., making the current situation particularly alarming. The FDA has not identified any other brands or sources of contamination related to the outbreak, but the investigation continues.

ByHeart, which holds about 1% of the U.S. infant formula market, had been distributing approximately 200,000 cans of the formula monthly prior to the recall. The company previously faced scrutiny in 2022 when it recalled five batches of formula due to contamination concerns linked to another bacteria, cronobacter sakazakii.

Federal officials have reassured the public that there is minimal risk of a nationwide infant formula shortage as a result of this incident, given ByHeart’s relatively small market share. This contrasts sharply with the widespread shortages experienced in 2021 and 2022, which were linked to separate contamination issues at Abbott Nutrition.

The FDA and CDC continue to monitor the situation closely, with further testing and results expected in the coming weeks. The ongoing efforts aim to ensure the safety of infant foods and protect vulnerable consumers from preventable illnesses.