The California Department of Public Health reported that preliminary tests indicated ByHeart baby formula contained bacteria linked to a botulism outbreak affecting at least 13 infants across 10 states. No fatalities have been documented, reports BritPanorama.
The affected infants, aged between 2 weeks and 5 months, were all hospitalized after consuming ByHeart’s powdered formula. The outbreak has prompted health authorities to urge consumers to stop using the product immediately. ByHeart has voluntarily recalled two specific lots of the formula.
State and federal investigations are ongoing, with additional tests of ByHeart Whole Nutrition Infant Formula pending. The outbreak began in mid-August, raising concerns as officials work to determine the exact source of the contamination. The company, based in New York, recalled product with a best-by date of December 2026.
California health officials confirmed that a can of the affected powdered formula was tested from a baby who fell ill, suggesting the presence of the bacteria responsible for botulism. The results from further testing may take several days, although ByHeart representatives indicated that “more testing is needed” to ascertain the presence of the bacteria.
Infant botulism outbreak
The U.S. Centers for Disease Control and Prevention indicated that the ongoing outbreak has led to hospitalizations in multiple states including Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. ByHeart officials confirmed their agreement to recall the affected lots.
The company emphasized that the bacteria belongs to a larger family, with many species found in the environment that typically do not cause illness. Health officials have reported 83 cases of infant botulism since August, although not all have been traced back to ByHeart products. ByHeart reiterated its commitment to safety, stating, “We take this very seriously” in response to the developing situation.
Causes of infant botulism
Infant botulism affects fewer than 200 babies in the U.S. annually, typically caused by bacteria that release toxins in the intestines. Infants under one year old are particularly susceptible, often contracting the illness via exposure to spores in their environment or potentially through contaminated honey.
Symptoms can include feeding difficulties, loss of head control, and respiratory problems, sometimes requiring hospitalization and ventilation support. The only treatment currently available, known as BabyBIG, has been administered to all affected infants as part of their medical care.
Potential impact on U.S. formula supplies
Despite the ongoing investigation, federal health officials have assured the public that there is no immediate risk of infant formula shortages resulting from this outbreak. ByHeart, founded in 2016, represents about 1% of the national formula market, in contrast to previous crises that led to widespread shortages from larger companies.
In earlier incidents, including a notable recall from Abbott linked to severe infant illnesses, significant supply disruptions occurred. ByHeart’s previous recall in 2022 over a different bacterial contamination underlines the scrutiny currently faced by infant formula manufacturers.
Reviewing infant formula ingredients
Federal health authorities, led by Health Secretary Robert F. Kennedy Jr., are conducting a comprehensive review of infant formula ingredients, part of an initiative titled “Operation Stork Speed.” This examination marks the first thorough assessment since 1998 and aims to improve the safety and quality of formula for American infants.
The FDA is currently deliberating on various industry and public comments to chart the next steps in this effort. As scrutiny increases, the health and safety of infants remain paramount amidst these systemic challenges facing the formula supply chain.
The response to this outbreak, coupled with regulatory evaluations, signals a critical moment for infant health policy and product safety in the United States.
