Botulism outbreak sickens more than 50 babies and expands to all ByHeart
products
[December 11, 2025]
By JONEL ALECCIA
Federal health officials on Wednesday expanded an outbreak of infant
botulism tied to recalled ByHeart baby formula to include all illnesses
reported since the company began production in March 2022.
The U.S. Food and Drug Administration said investigators “cannot rule
out the possibility that contamination might have affected all ByHeart
formula products” ever made.
The outbreak now includes at least 51 infants in 19 states. The new case
definition includes “any infant with botulism who was exposed to ByHeart
formula at any time since the product's release,” according to the U.S.
Centers for Disease Control and Prevention. The most recent illness was
reported on Dec. 1.
No deaths have been reported in the outbreak, which was announced Nov.
8.
Previously, health officials had said the outbreak included 39 suspected
or confirmed cases of infant botulism reported in 18 states since
August. That's when officials at California's Infant Botulism Treatment
and Prevention Program reported a rise in treatment of infants who had
consumed ByHeart formula. Another 12 cases were identified with the
expanded definition, including two that occurred in the original
timeline and 10 that occurred from December 2023 through July 2025.
ByHeart, a New York-based manufacturer of organic infant formula founded
in 2016, recalled all its products sold in the U.S. on Nov. 11. 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.
News that ByHeart products could have been contaminated for years was
distressing to Andi Galindo, whose 5-week-old daughter, Rowan, was
hospitalized in December 2023 with infant botulism after drinking the
formula. Galindo, 36, of Redondo Beach, California, said she insisted on
using ByHeart formula to supplement a low supply of breast milk because
it was recommended by a lactation consultant as “very natural, very
gentle, very good for the babies."
“That's a hard one,” Galindo said. “If there is proof that there were
issues with their manufacturing and their plant all the way back from
the beginning, that is a problem and they really need to be held
accountable."
Amy Mazziotti, 43, of Burbank, California, said her then-5-month-old
son, Hank, fell ill and was treated for botulism in March, weeks after
he began drinking ByHeart. Being included in the investigation of the
outbreak “feels like a win for all of us,” she said Wednesday.
“I’ve known in my gut from the beginning that ByHeart was the reason
Hank got sick, and to see that these cases are now part of the
investigation brings me to tears — a mix of relief, gratitude and hope
that the truth is finally being recognized,” she said.
In a statement late Wednesday, ByHeart officials said the company is
cooperating with federal officials “to understand the full scope of
related cases.”
“The new cases reported by CDC and FDA will help inform ByHeart’s
investigation as we continue to seek the root cause of the
contamination,” the statement said.
Lab tests detected contamination
The FDA sent inspectors last month to ByHeart plants in Allerton, Iowa,
and Portland, Oregon, where the formula is produced and packaged. The
agency has released no results from those inspections.
The company previously reported that tests by an independent laboratory
showed that 36 samples from three different lots contained the type of
bacteria that can cause infant botulism.
“We cannot rule out the risk that all ByHeart formula across all product
lots may have been contaminated,” the company wrote on its website last
month.
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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, File)
 Those results and discussions with
the FDA led CDC officials to expand the outbreak, according to Dr.
Jennifer Cope, a CDC scientist leading the investigation.
“It looks like the contamination appeared to persist across all
production runs, different lots, different raw material lots,” Cope
said. “They couldn't isolate it to specific lots from a certain time
period.”
Inspection documents showed that ByHeart had a history of problems
with contamination.
In 2022, the year ByHeart started making formula, the company
recalled five batches of infant formula after a sample at a
packaging plant tested positive for a different germ, cronobacter
sakazakii. In 2023, the FDA sent a warning letter to the company
detailing “areas that still require corrective actions.”
A ByHeart plant in Reading, Pennsylvania, was shut down in 2023 just
before FDA inspectors found problems with mold, water leaks and
insects, documents show.
Infant botulism is rare
Infant botulism is a rare disease that affects fewer than 200 babies
in the U.S. each year. It’s caused when infants ingest botulism
bacteria that produce spores that germinate in the intestines,
creating a toxin that affects the nervous system. Babies are
vulnerable until about age 1 because their gut microbiomes are not
mature enough to fight the toxin.
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.
Symptoms can take up to 30 days to develop and can include
constipation, poor feeding, loss of head control, drooping eyelids
and a flat facial expression. Babies may feel “floppy” and can have
problems swallowing or breathing.
The sole treatment for infant botulism 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.
The antibodies provided by BabyBIG are likely most effective for
about a month, although they may continue circulating in the child's
system for several months, said Dr. Sharon Nachman, an expert in
pediatric infectious disease at Stony Brook Children's Hospital.
“The risk to the infant is ongoing and the family should not be
using this formula after it was recalled,” Nachman said in an email.
Families of several babies treated for botulism after drinking
ByHeart formula have sued the company. 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.
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