The United States is in the midst of a botulism outbreak linked to a brand of premium infant formula. Dozens of babies have been affected as of November 19.
All of the reported cases of crippling bacterial infection occurred between August and November and have been linked to powdered infant formula produced by ByHeart, according to a Food and Drug Administration Report. The company voluntarily recalled all of its products on Nov. 11, and experts warn that more cases of the potentially deadly disease may emerge.
“In some cases, after exposure, it may have taken up to a month for some babies to show symptoms,” says Randal De Souza, a pediatric infectious disease specialist at the University of Kentucky Golisano Children’s Hospital.
About supporting scientific journalism
If you are enjoying this article, please consider supporting our award-winning journalism by subscribing. By purchasing a subscription, you help ensure the future of impactful stories about the discoveries and ideas that shape our world today.
As of November 19, the FDA and Centers for Disease Control and Prevention They are currently investigating illnesses in infants in several states, including Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas, and Washington state..
In an email to american scientist, ByHeart co-founder and president Mia Funt said the company was working with the FDA and independent experts on product recalls and ongoing investigations.
“Our number one priority is children’s health. We express our deepest condolences to the families currently affected by cases of childhood botulism,” Funt wrote. The FDA did not immediately respond to a request for comment from American scientist.
Here’s what you should know about the outbreak and how to stay safe.
What to know about the outbreak of botulism in babies
Botulism is a relatively rare but potentially serious infection caused by soil-dwelling bacteria. botulinum clostridium. The bacteria produces toxins that damage the nerves, says De Souza. According to the most recent CDC dataThere were 243 laboratory-confirmed cases in the US in 2021, and 181 of those infections occurred in infants. Between 5 and 10 percent of cases are fatal.
In babies, the first signs of infection are usually constipation, followed by varying degrees of paralysis. Initially, babies may lose control of their facial expressions, mouth, and eyes. They might also drool more, take longer to feed, or cry more weakly, says De Souza. Paralysis slowly progresses through the body, he explains.
“The presentation tends to be that of a ‘limp baby,’ which basically means first you lose control of your head, then you lose control of your limbs, and lastly it tends to be breathing—you lose the ability to breathe,” De Souza says.
How are infected babies diagnosed and treated?
A clinical diagnosis, using stool samples, can take up to a week, so any baby with a suspected case of botulism should be monitored closely, says De Souza.
If babies are hospitalized, feeding tubes are placed and they may be intubated. Infections are treated with an antitoxin that binds to and neutralizes excess toxins in the body to stop the infection.
“Then it is up to the body to essentially regenerate the nerves,” De Souza says. That process can take weeks or months, and some babies may need more speech or feeding therapy. In extreme cases, they may need a breathing tube.
Babies who recover from botulism are not known to have permanent problems, De Souza says, but “a very small baby requiring multiple modalities of support for months is not good.”
The 23 babies who were infected in the recent outbreak (almost all of them are currently less than seven months old) have been hospitalized and no deaths have been reported.
How to stay safe
ByHeart and the FDA are warning people not to use recently purchased ByHeart infant formula. Barbara Kowalcyk, director of the Institute for Food and Nutrition Security at George Washington University, recommends checking any ByHeart formula parents may have in storage.
“People have things in their pantries that they don’t always know about, or maybe they don’t hear about the recall,” Kowalcyk says. “The language of voluntary withdrawal can potentially lead people to believe that it’s not that big of a problem.”
He suspects that more cases of botulism will be discovered in the coming weeks.
Is baby formula particularly susceptible to botulism?
Botulism has been detected in baby formula before. The pathogen exists primarily as a resistant spore, and while high pressure or industrial-level heat can kill them, “typical heating, for example, of your home kitchen, will not,” says De Souza. Otherwise, “the spores just live forever.”
According to the Infant Botulism Treatment and Prevention Program (IBTPP), 84 babies in the U.S. have been treated for botulism since August, and at least 36 of those cases have been linked to exposure to powdered infant formula. He California Department of Public Health found at least six cases of infant botulism linked to exposure to ByHeart powdered formula that occurred between November 2024 and June 2025, months before the current outbreak.
It is not clear if C. botulinum The contamination occurred at any point during the manufacturing process at ByHeart facilities or in stores that sold the product or in people’s homes after that process. He California Department of Public Health reported on Nov. 8 that an already opened can of ByHeart formula tested positive for C. botulinum, and officials are now testing unopened products for the bacteria.
in an open letter to the fdaByHeart alluded to a broader “unprecedented rise” in childhood botulism nationwide. IBTPP representatives have also said that the increase in cases may be indicative of a broader trendreported Associated Press.
Other bacteria can also contaminate infant formula. In 2022, ByHeart recalled products due to contamination with Cronobacter sakazakii, a pathogen that can cause fatal infections in babies. In 2023, the company stopped producing formula at a Pennsylvania facility due to several security breaches, according to the fda. ByHeart said American scientist that the Pennsylvania facility has not produced infant formula since 2023 and is not related to the current recall.
In 2022 and 2023, Abbott and Reckitt/Mead Johnson Nutrition, two of the nation’s largest infant formula manufacturers, were at the center of a major national shortage after conducting voluntary recalls of C. sakazakii detections. ByHeart products represent about 1 percent of all infant formula sold in the U.S., according to the FDA. Kowalcyk doesn’t expect ByHeart’s recall to lead to similar shortages, but says the incident reflects a broader worrying trend in food safety oversight.
“I think historically there’s been this tendency to say that low-moisture foods are not a good environment for pathogens to grow,” he says. “And with these recent outbreaks, we have to rethink that.”
Editor’s Note (11/19/25): This story has been updated to reflect recently reported cases of infant botulism and additional states linked to the recall of ByHeart formula.
Editor’s note (11/24/25): This story has been updated to include more information about more cases of botulism linked to powdered infant formula.
#botulism #baby #formula #Heres #kids #safe
