A significant outbreak of botulism associated with ByHeart infant formula has resulted in the hospitalization of **51 infants** across **19 states** in the United States. The **Food and Drug Administration (FDA)** announced the alarming increase in cases on **December 10, 2023**, highlighting the serious nature of the disease, which can lead to paralysis and even death.
The outbreak, which has been confirmed through extensive testing, includes cases of infants who consumed ByHeart formula from **August 1, 2025**, onward. The CDC and state health officials expanded their investigation definition, uncovering an additional **10 cases** occurring between **December 2023** and **July 2025**. All affected infants have been hospitalized, although no fatalities have been reported thus far.
Illnesses linked to the outbreak began between **August 9** and **November 19**, and 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**. Ohio is the latest state added to the list.
The FDA confirmed that it has not received reports of recalled formula being found on store shelves since **November 26, 2025**. In response to the outbreak, the agency has mandated a recall of all ByHeart infant formula products. “These products should not be available for sale in stores or online,” the FDA stated. This includes all cans and single-serve “anywhere pack” sticks of ByHeart formula.
On **December 3, 2023**, concerns were raised when consumers reported finding ByHeart products on the shelves of major retailers, including **Walmart, Target**, and **Kroger**, despite the ongoing recall. ByHeart, which claims a mere **1%** of the U.S. infant formula market, previously marketed around **200,000 cans** of its formula each month.
Ongoing investigations and testing by ByHeart, the FDA, the **Centers for Disease Control and Prevention (CDC)**, and state partners are underway, with results expected in the coming weeks. Parents and caregivers are advised to stop using the recalled formula immediately and to dispose of any remaining products.
The FDA has identified certain lots of **ByHeart Whole Nutrition Infant Formula** as recalled, which have been linked to the outbreak. The infants affected range in age from **2 weeks** to **5 months**, and all cases have been associated with consumption of the powdered formula.
A sample from an open can of ByHeart formula, fed to an ill infant in **California**, tested positive for the toxin-producing bacteria responsible for botulism. Dr. **Erica Pan**, California’s state health officer, explained that confirmation of contamination involved testing on mice, which became ill shortly after being injected with the cultured bacterium.
As investigations continue, officials have not identified any other brands of infant formula or alternative sources of exposure. ByHeart released a statement on **November 9, 2023**, indicating they are conducting tests with an independent laboratory to ensure safety. They emphasized their swift action to recall the affected batches as soon as they were notified by the FDA.
Despite ongoing concerns, experts suggest that the current outbreak is unlikely to lead to widespread formula shortages, given ByHeart’s small market share. This contrasts sharply with the **2021-2022** crisis involving **Abbott Nutrition**, which resulted in severe shortages following a contamination inquiry where four infants fell ill, leading to two fatalities.
Infant botulism is a rare but serious disease, typically affecting fewer than **200 babies** in the U.S. annually. It is caused by a bacterium that produces a toxin in the intestines of infants. Notably, infants are especially susceptible due to their underdeveloped gut microbiomes.
Symptoms of botulism can take weeks to manifest and may include poor feeding, loss of head control, drooping eyelids, and a flat facial expression. If untreated, the condition can lead to severe complications. The primary treatment available, known as **BabyBIG**, is an intravenous medication derived from the blood plasma of adults immunized against botulism. All affected children in the current outbreak have received this treatment, which costs approximately **$69,300** per vial.
As investigations continue to unfold, both the FDA and ByHeart are committed to addressing safety concerns and preventing further incidents related to infant formula consumption.
