Botulism Outbreak Linked to ByHeart Formula Affects 51 Infants

A significant outbreak of infant botulism linked to ByHeart baby formula has resulted in 51 hospitalizations across 19 states, according to the Food and Drug Administration (FDA). As health officials continue their investigation, the situation has raised serious concerns regarding the safety of infant nutrition products.

The FDA reported that the illnesses, confirmed or suspected, stem from infants who consumed the ByHeart formula. This marks an increase from the earlier count of 39 cases involving 18 states. The reported cases have been recorded from August 1, 2025, onwards, though the expanded definition now includes additional cases identified between December 2023 and July 2025. All affected infants have been hospitalized, but there have been no fatalities to date.

Cases of botulism began to emerge between August 9 and November 19, affecting infants aged 2 weeks to 5 months. The states reporting cases include Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin. Notably, Ohio has recently been added to the list.

Recall and Safety Measures

In response to the outbreak, the FDA has issued a recall for all ByHeart infant formula products. The agency emphasized that these items should no longer be available for sale in stores or online, including all formula cans and “anywhere pack” sticks. Despite this, some consumers reported finding recalled products on shelves at major retailers such as Walmart, Target, and Kroger as recently as December 3, 2025.

ByHeart, which commands approximately 1% of the U.S. infant formula market, had previously sold around 200,000 cans of its product each month. The company is actively collaborating with the FDA, CDC, and state health officials to conduct further testing, with results expected in the coming weeks. Parents and caregivers are advised to cease the use of all ByHeart products and dispose of any remaining formula.

Dr. Erica Pan, the state health officer in California, confirmed that a sample from an open can of ByHeart formula fed to an infant who fell ill tested positive for the botulism-causing bacteria. This bacterium can be found in various environmental sources, and health officials have not linked the outbreak to any other infant formula brands.

Understanding Botulism and Its Effects

Botulism is a rare but severe illness that can lead to paralysis and death, particularly in infants whose digestive systems are still developing. Symptoms may take weeks to present and include poor feeding, loss of head control, drooping eyelids, and difficulty swallowing or breathing. The only treatment available is known as BabyBIG, an intravenous medication made from pooled blood plasma of adults immunized against botulism.

The Centers for Disease Control and Prevention (CDC) noted that all infants affected by the ByHeart outbreak have received this crucial treatment, which costs approximately $69,300 per vial. Experts indicate that while this incident is alarming, it is unlikely to lead to significant shortages of infant formula, given ByHeart’s relatively small share of the market.

Historically, infant botulism affects fewer than 200 babies annually in the U.S. The recent outbreak, while serious, recalls earlier crises, such as the one involving Abbott Nutrition in 2021 and 2022, which resulted in a nationwide formula shortage following contamination issues. No direct link was established between Abbott products and other illnesses caused by different bacteria, yet the fallout from those events continues to influence consumer perceptions and regulatory actions in the industry.

As investigations continue, the FDA urges vigilance among parents and caregivers, emphasizing the importance of not using any recalled products and reporting any adverse health effects to health authorities.