Federal health officials have confirmed that a botulism outbreak linked to ByHeart infant formula has resulted in hospitalization for 51 infants across 19 states. The outbreak, which has expanded from earlier reports, raises significant health concerns as the rare but serious disease can lead to paralysis and death. The Food and Drug Administration (FDA) reported the latest figures on December 10, 2023, noting that all affected infants consumed ByHeart powdered formula.
The outbreak has prompted an increase in reported cases from 39 to 51, with illnesses occurring from August 1, 2025, onward. This new definition includes additional cases identified by the Centers for Disease Control and Prevention (CDC) and state health partners, who found 10 more cases from December 2023 through July 2025. Fortunately, no fatalities have been reported in connection with this outbreak.
Illnesses among infants began between August 9 and November 19, with cases reported in states including Arizona, California, Illinois, Kentucky, and Ohio, among others. Ohio has recently been added to the list of affected states. The FDA has not received reports of recalled formula being found in stores since November 26, 2025, indicating that the recall measures are being followed.
The FDA stated, “All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online.” This recall encompasses all formula cans and single-serve “anywhere pack” sticks. Despite the ongoing recall, some consumers have reported finding ByHeart products in stores such as Walmart and Target, raising concerns about compliance.
ByHeart, which holds approximately 1% of the U.S. infant formula market, was previously selling about 200,000 cans of its product each month. The latest testing and investigations involving the FDA, CDC, and state health officials are ongoing, with results anticipated in the coming weeks. In light of the situation, ByHeart officials have advised parents and caregivers to immediately stop using the formula and dispose of any recalled products.
The CDC confirmed that the infants affected were hospitalized after consuming the ByHeart powdered formula. California health authorities identified contamination in a sample from an open can of ByHeart formula that had been fed to an ill infant. Testing procedures for confirming contamination involve injecting laboratory mice with the cultured bacterium and monitoring them for symptoms.
In response to the outbreak, ByHeart issued a statement on November 9, 2023, indicating their commitment to public safety. The company stated, “We are conducting testing, with a third-party independent testing laboratory, of the two recalled batches of our formula using food safety testing best practices.” They emphasized their proactive approach in cooperating with the FDA and urged customers to dispose of recalled products.
Botulism, a rare disease that affects fewer than 200 infants in the U.S. annually, can cause severe illness. The bacterium that produces the toxin responsible for botulism is commonly found in the environment and can lead to serious health complications, particularly in infants whose digestive systems are not fully developed. Symptoms may take weeks to manifest and can include poor feeding, loss of head control, drooping eyelids, and difficulty swallowing.
The only known treatment is BabyBIG, an intravenous medication derived from the pooled blood plasma of adults immunized against botulism. The CDC confirmed that all affected infants have received this treatment, which costs approximately $69,300 per vial.
Experts indicate that there is minimal risk of a nationwide infant formula shortage due to ByHeart’s relatively small market share, contrasting sharply with the significant shortages experienced in late 2021 and early 2022. At that time, a separate issue involving Abbott Nutrition led to recalls and supply chain disruptions that affected infant formula availability across the country.
In 2022, ByHeart faced its own challenges when several batches of its formula were recalled after contamination with a different bacterium, cronobacter sakazakii. The FDA has been monitoring the company, sending a warning letter highlighting necessary corrective actions.
As investigations continue, the focus remains on protecting the health of infants and ensuring that parents are informed about the risks associated with contaminated products.
