Cases jump to 23 in the botulism outbreak tied to baby formula. Here's
what to know
[November 15, 2025]
By JONEL ALECCIA
Nearly two dozen babies in 13 states have been sickened in a growing
outbreak of infantile botulism linked to recalled ByHeart infant
formula, federal health officials said Friday.
The U.S. Food and Drug Administration reported 23 cases of confirmed or
suspected illness in babies who consumed ByHeart formula since August.
That's an increase of 10 babies treated for the rare and potentially
deadly disease since the outbreak was announced Nov. 8. The most recent
case was reported on Nov. 11.
No deaths have been reported.
“Parents and caregivers should stop using any ByHeart infant formula
products immediately,” the FDA said.
ByHeart, a New York-based manufacturer of organic infant formula, has
recalled all its products sold in the U.S. The company, which accounts
for about 1% of the U.S. infant formula market, had been selling about
200,000 cans of the product each month.
It can take up to 30 days for symptoms of infantile botulism to develop,
medical experts said.
Here’s what to know about the outbreak and infant botulism.
The outbreak begins
The outbreak has sickened babies aged about 2 weeks to about 6 months,
the FDA said. All the infants were hospitalized after consuming ByHeart
powdered formula.
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 can lead to illness.
ByHeart officials said they recalled their products “in close
collaboration” with the FDA, despite the fact that no previously
unopened product tested positive for the illness-causing bacteria. The
type of bacteria that produces the toxin is widespread in the
environment and could come from sources other than the formula, company
officials have said.
FDA inspectors have been to the company's infant formula production
plants in Allerton, Iowa; and Portland, Oregon, this week.
Families of at least two babies treated for botulism after drinking
ByHeart formula sued the company this week. Lawsuits filed in federal
courts allege that the formula they fed their children was defective and
ByHeart was negligent in selling it. They seek financial payment for
medical bills, emotional distress and other harm.
The FDA is investigating a rise in cases of infantile botulism. Since
August, at least 84 babies have been treated for the disease, which
represents “an increasing trend line of cases," according to Dr. Jessica
Khouri, senior medical officer at California's Infant Botulism Treatment
and Prevention Program.
Many of those babies consumed ByHeart formula, which Khouri called
“unprecedented” for exposure to a common product in a short period of
time.
The FDA said that shows that “ByHeart brand formula is
disproportionately represented among sick infants in this outbreak.”
Illnesses began between Aug. 9 and Nov. 11, federal officials said.
Cases were reported in Arizona, California, Illinois, Kentucky,
Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania,
Rhode Island, Texas and Washington.
Investigators have not identified any other infant formula brands or
other sources of exposure in the outbreak, officials said.
Causes of infant botulism
Infant botulism typically affects fewer than 200 babies in the U.S. each
year. As of Sept. 20, 133 cases had been reported in the U.S. according
to the most recent Centers for Disease Control and Prevention records.
There were 145 cases reported all of last year.
The infection 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.
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Stephen Dexter holds a container of ByHeart baby formula, which was
recently recalled by ByHeart, in Flagstaff, Ariz., on Wednesday,
Nov. 12, 2025. (AP Photo/Cheyanne Mumphrey)
 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.
Baby formula has previously been linked to sporadic cases of
illness, but no known outbreaks of infant botulism tied to powdered
formula have previously been confirmed, according to research
studies.
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 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. The treatment is delivered in vials that
cost $69,300 apiece, California officials 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
nationwide shortage that lasted months.
In 2022, ByHeart recalled five batches of infant formula after a
sample at the company's packaging plant tested positive for
cronobacter sakazakii. 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 FDA 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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