What to Know
- Infant botulism typically affects fewer than 200 babies in the U.S. each year. It’s caused by a type of bacteria that produces toxins in the large intestine and can cause serious illness, including paralysis.
- An outbreak that has hospitalized at least 15 babies since mid-August has been linked to baby formula from NYC-based company ByHeart; one of the babies is from NJ, another from NY
- The only treatment is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism.
- There is no danger of infant formula shortages because of this outbreak. ByHeart accounts for an estimated 1% of national formula sales, the CDC says. The company sells formula through its website and in retail stores nationwide.
ByHeart, a New York-based company that makes organic infant formula, recalled all of its products sold throughout the U.S. Tuesday amid a growing outbreak of infant botulism that the company co-founders say has “still too many unanswered questions.”
At least 15 babies in 12 states, including New York and New Jersey, have been sickened in the outbreak tied to ByHeart formula, state and federal health officials now say. That’s an increase from 13 cases in 10 states reported Saturday.
“We’re writing to you today to tell you that we have decided to voluntarily recall all ByHeart formula nationwide—this includes both our cans and our single-serve Anywhere Pack™ sticks. This decision was made to ensure your baby’s safety,” Byheart co-founders Mia Funt and Ron Belldegrun said in an open letter on their website.
“The decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point,” the letter, posted Tuesday, read. “The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions. Your baby’s safety is, and always will be, our biggest priority.”
While the products have not been confirmed to be the cause of the illnesses, the co-founders urged people to get rid of any ByHeart product they have.
No deaths have been reported in the outbreak, which began in mid-August. The New York case involves a patient on Long Island, in Nassau County, currently in the hospital. Health officials there say the affected child is younger than a year old and consumed the contaminated product.
New Jersey health officials issued an alert Tuesday about the outbreak, confirming the state’s hospitalized case. No other details about that baby were provided.
“While infant botulism remains rare, it is a serious illness that requires immediate medical attention. We urge parents and caregivers to check their infant formula and stop using any product from the affected lots,” New Jersey Acting Health Commissioner Jeff Brown said in a statement. “Quick recognition of symptoms and prompt treatment are key. Our priority is ensuring every infant’s safety as we work with our federal and state partners to investigate this outbreak and prevent future cases.”
Here’s what to know about the outbreak and infant botulism. Learn how ByHeart is supporting customers here.
Infant botulism outbreak
The outbreak of infant botulism has sickened babies aged 2 weeks to 5 months since mid-August. All were hospitalized after consuming ByHeart powdered formula, according to the U.S. Centers for Disease Control and Prevention.
California officials confirmed that a sample from an open can of ByHeart baby formula fed to an infant who fell ill contained the type of bacteria that causes the toxin linked to the outbreak. The tests to confirm contamination involve injecting mice with the cultured bacterium and then waiting up to four days to see if they get sick.
“These mice got sick really quickly,” Pan said in an interview.
ByHeart officials said they recalled their products “in close collaboration” with the U.S. Food and Drug Administration, “despite the fact that no unopened ByHeart product” tested positive for the illness-causing bacteria. Investigators have not confirmed whether the bacteria is active, widespread or definitely the cause of all cases. More testing is ongoing.
The FDA is investigating 84 cases of infant botulism detected since August. Of those, 36 consumed infant formula — more than a third of them ByHeart’s formula, the agency said in a statement.
“This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States,” the FDA said.
Causes of infant botulism
Infant botulism typically affects fewer than 200 babies in the U.S. each year. It is caused by a type of bacteria that produces a toxin in the large intestine. The bacterium is spread through hardy spores present in the environment that can cause serious illness, including paralysis.
Infants are particularly vulnerable to infection because their gut microbiomes are not developed enough to prevent the spores from germinating and producing the toxin. They can be sickened after exposure to the spores in dust, dirt or water or by eating contaminated honey.
Symptoms can take weeks to develop and can include poor feeding, loss of head control, drooping eyelids and a flat facial expression. Babies may feel “floppy” and can have problems swallowing or breathing.
No known outbreaks of infant botulism tied to powdered formula have previously been confirmed, said Dr. Steven Abrams, a University of Texas nutrition expert.
Infant botulism treatment
The only treatment is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California’s Infant Botulism Treatment and Prevention Program developed the product and is the sole source worldwide.
BabyBIG works to shorten hospital stays and decrease the severity of illness in babies with botulism. Because the infection can affect the ability to breathe, infants often need to be placed on ventilators.
All of the children in the ByHeart outbreak have received the medication, the CDC said.
Potential impact on U.S. formula supplies
There is little danger of infant formula shortages because ByHeart represents a small share of the market.
That’s far different from the crises in late 2021 and 2022, when four infants were sickened by a different germ after consuming formula made by Abbott Nutrition. Two of the babies died. No direct link was found between the Abbott products and the infections caused by a different germ, cronobacter sakazakii, but FDA officials closed the company’s Michigan plant after contamination and other problems were detected.
Abbott recalled top brands of infant formula, triggering a massive nationwide shortage that lasted for months.
In 2022, ByHeart recalled five batches of infant formula after a sample at the company’s packaging plant tested positive for cronobacter sakazakii, the germ at the heart of the Abbott crisis. In 2023, the FDA sent a warning letter to the company detailing “areas that still require corrective actions.”
Reviewing infant formula ingredients
Federal health officials have vowed to overhaul the U.S. food supply and are taking a new look at infant formula.
Health Secretary Robert F. Kennedy Jr. has directed the Food and Drug Administration to review the nutrients and other ingredients in infant formula, which fills the bottles of millions of American babies.
The effort, dubbed “Operation Stork Speed,” is the first deep look at the ingredients since 1998.
FDA officials are reviewing comments from industry, health experts and public to decide next steps.
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