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California health officials announced Saturday that preliminary tests have detected bacteria that produces botulism toxin in ByHeart baby formula, linking the product to a widespread infant illness outbreak that has affected at least 13 babies across 10 states since mid-August.
“Consumers in possession of this product should stop using it immediately,” the California Department of Public Health warned in its statement. While no deaths have been reported, all affected infants required hospitalization after consuming the powdered formula.
The outbreak spans across Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington, affecting babies between 2 weeks and 5 months old. In response to these findings, New York-based ByHeart has recalled two lots of its Whole Nutrition Infant Formula with a December 2026 best-by date.
California health officials tested a formula can that had been fed to one of the sickened babies. The initial results “suggest the presence” of bacteria that produces botulism toxin, though definitive confirmation requires several additional days of testing.
ByHeart acknowledged the situation in a Sunday statement, noting that “more testing is needed” while emphasizing they “take this very seriously.” The company pointed out that the bacteria in question belongs to a large family, many members of which occur naturally in the environment without causing illness.
Meanwhile, the FDA has expanded its investigation to include 83 total cases of infant botulism reported since August, with the ByHeart-linked cases representing a significant subset of this broader outbreak.
Infant botulism is a relatively rare condition, affecting fewer than 200 U.S. babies annually. The illness occurs when bacteria produce toxins in an infant’s large intestine, potentially causing serious complications including paralysis. Babies under one year are particularly vulnerable to the hardy bacterial spores, which can be present in dust, dirt, water, or honey.
The condition can take weeks to develop after exposure. Warning signs include poor feeding, loss of head control, drooping eyelids, flat facial expression, and a “floppy” feeling. Affected infants often experience difficulty swallowing or breathing.
Dr. Steven Abrams, a nutrition expert from the University of Texas, noted the exceptional nature of this outbreak, saying, “This would be extremely rare.” According to Abrams, no known outbreaks of infant botulism connected to powdered formula have previously been confirmed.
The only available treatment for infant botulism is an intravenous medication called BabyBIG, developed by California’s Infant Botulism Treatment and Prevention Program. Made from the pooled blood plasma of adults immunized against botulism, this medication helps shorten hospital stays and reduce illness severity. The CDC has confirmed that all children in the current outbreak have received this treatment.
Despite the recall, health officials do not anticipate formula shortages similar to the 2022 crisis that followed Abbott’s product contamination. ByHeart, founded in 2016, represents only about 1% of national formula sales, according to CDC estimates. The company sells its products through its website and retail stores nationwide.
This isn’t ByHeart’s first safety concern. In 2022, the company recalled five batches of infant formula after detecting cronobacter sakazakii—the same bacterium involved in the Abbott crisis—in a sample from its packaging plant. In 2023, the FDA sent the company a warning letter outlining “areas that still require corrective actions.”
The current outbreak comes as federal health officials undertake a comprehensive review of infant formula ingredients. Health Secretary Robert F. Kennedy Jr. has directed the FDA to examine nutrients and other components in formula products, the first such extensive review since 1998. Dubbed “Operation Stork Speed,” this initiative aims to modernize standards for products that nourish millions of American babies.
FDA officials are currently reviewing input from industry stakeholders, health experts and the public before determining next steps in this regulatory overhaul.
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12 Comments
This is certainly an alarming situation. Baby formula contamination is always concerning, as the health and safety of infants is paramount. I hope the authorities are able to quickly identify the source and take appropriate action to protect consumers.
Agreed. It’s critical that the root cause is determined and any tainted product is swiftly recalled to prevent further illness. The wellbeing of these young babies must be the top priority.
Contamination in baby formula is always a serious matter. With infants and young children being the consumers, the safety standards have to be the highest possible. I’m glad the authorities are acting quickly to identify the source and remove any tainted product from the market.
Botulism is an extremely dangerous toxin, so finding it in baby formula is frightening. I hope the authorities are able to quickly identify the source and ensure all contaminated product is removed from store shelves. The health and wellbeing of these infants has to be the top priority.
While no deaths have been reported, any contamination that leads to hospitalization of infants is a grave concern. The regulators and ByHeart will need to conduct a thorough investigation to determine how this breakdown in quality control occurred, and implement robust measures to ensure it doesn’t happen again.
This is a deeply troubling development. Infant formula should be one of the most meticulously regulated and safeguarded consumer products, yet this breakdown in quality control has put vulnerable babies at risk. I hope the investigation uncovers the root cause and leads to swift action to protect public health.
Infant formula should be one of the most rigorously tested and safest consumer products on the market. The fact that this contamination slipped through is very concerning. Regulators will need to closely scrutinize the manufacturing processes at ByHeart to determine the root cause.
You’re right, the safety standards for infant formula have to be exceptionally high. Any breakdown in quality control can put vulnerable babies at serious risk. This situation underscores the need for even tighter oversight and accountability across the industry.
Botulism is a very serious condition, so finding it in baby formula is deeply troubling. I’m glad no deaths have been reported so far, but the hospitalizations are still very concerning. Rigorous testing and oversight of the supply chain is clearly needed to ensure infant formula safety.
Absolutely. The manufacturers and regulators will need to conduct a thorough investigation to understand how this contamination occurred and implement robust quality control measures to prevent similar issues in the future.
This is an extremely troubling situation. Infant formula is a critical source of nutrition for babies, so any contamination is unacceptable. I hope the authorities are able to quickly pinpoint the root cause and work with the manufacturer to recall all affected product and prevent further illness.
This is a stark reminder of the importance of safety and quality control in the infant formula industry. Consumers put their trust in these products to nourish their babies, so any lapse can have devastating consequences. I hope the authorities get to the bottom of this quickly.