The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo)
California health officials have confirmed that preliminary tests detected traces of bacteria capable of producing botulism toxin in ByHeart baby formula, prompting urgent warnings and a nationwide recall.
The outbreak, which began in mid-August, has affected at least 13 infants across 10 U.S. states. All babies, aged between two weeks and five months, were hospitalized after consuming the powdered formula. No deaths have been reported so far.
Officials urged parents to stop using the product immediately. “Consumers in possession of this product should stop using it right away,” the California Department of Public Health said in a statement released Saturday.
Nationwide Recall and Ongoing Investigation
The New York-based company ByHeart has voluntarily recalled two batches of its Whole Nutrition Infant Formula with a best-by date of December 2026. The recall comes as state and federal agencies continue testing to determine the extent of contamination.
Health authorities said a can of the formula tested in California showed signs of bacteria that produce the same toxin confirmed in other botulism cases. However, officials noted that it could take several more days for full confirmation.
ByHeart stated on Sunday that more testing is underway. “We take this very seriously,” the company said, emphasizing that many bacteria in the same family are harmless and naturally found in the environment.
The U.S. Food and Drug Administration (FDA) is also investigating 83 reported cases of infant botulism since August, including those linked to the ByHeart formula.
How the Outbreak Spread
The affected cases were reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. According to the U.S. Centers for Disease Control and Prevention (CDC), all infected infants had consumed the recalled ByHeart powdered formula.
Infant botulism is rare, typically affecting fewer than 200 babies in the United States each year. The illness occurs when a specific type of bacteria produces toxins in the large intestine. Spores from this bacterium exist widely in the environment — in soil, dust, or even water — and can sometimes contaminate food sources.
Infants under one year old are especially vulnerable because their digestive systems are not mature enough to destroy the spores.
Symptoms and Treatment
Symptoms of infant botulism may take weeks to appear. They can include poor feeding, drooping eyelids, weak muscle tone, trouble swallowing, and breathing difficulties.
Treatment involves BabyBIG — an intravenous medication made from plasma collected from adults immunized against botulism. Developed by California’s Infant Botulism Treatment and Prevention Program, it remains the only approved treatment worldwide.
According to the CDC, all infants affected in the current outbreak have received the medication. BabyBIG helps reduce the severity of symptoms and shortens hospital stays, though some babies still require ventilator support.
Experts Call This a Rare Case
Health experts say it’s extremely uncommon for powdered formula to be linked to botulism. Dr. Steven Abrams, a nutrition specialist from the University of Texas, called the situation “extraordinarily rare.”
He noted that while isolated cases of infant botulism occur each year, outbreaks connected to formula are virtually unheard of.
Formula Supply Unaffected
Authorities have clarified that the ByHeart recall will not lead to formula shortages. The company accounts for only about one percent of the nation’s infant formula sales, distributed both online and in retail stores.
This situation differs from the 2021–2022 crisis, when Abbott Nutrition recalled several major formula brands following contamination issues at its Michigan plant. That incident disrupted national supplies for months.
ByHeart itself had recalled five batches of formula in 2022 after tests at its packaging facility detected cronobacter sakazakii, the same germ involved in the Abbott case. The FDA later issued a warning letter in 2023, highlighting “areas that still require corrective actions.”
Renewed Focus on Formula Safety
In response to recent safety concerns, U.S. health officials are reviewing how infant formula is regulated. Under “Operation Stork Speed,” the FDA is reassessing the nutrients and ingredients in all baby formulas — marking the first major review since 1998.
The agency is now collecting feedback from medical experts, industry leaders, and the public to ensure stronger safety standards and improved oversight for the millions of babies who rely on formula every day.
