Babies who drank ByHeart formula got sick months before botulism
outbreak, parents say
[November 24, 2025]
By JONEL ALECCIA
As health officials investigate more than 30 cases of infant botulism
linked to ByHeart baby formula since August, parents who say their
children were sickened with the same illness months before the current
outbreak are demanding answers, too.
California public health officials confirmed late Friday that six babies
in that state who consumed ByHeart formula were treated for botulism
between November 2024 and June 2025, up to nine months before the
outbreak that has sickened at least 31 babies in 15 states.
At the time, there was “not enough evidence to immediately suspect a
common source," the California Department of Public Health said in a
statement.
Even now, "we cannot connect any pre-August 1 cases to the current
outbreak,” officials said.
Parents of at least five babies said that their infants were treated for
the rare and potentially deadly disease after drinking ByHeart formula
in late 2024 and early 2025, according to reports shared with The
Associated Press by Bill Marler, a Seattle food safety lawyer
representing the families.
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 bottles filled with ByHeart formula.
Katie Connolly, 37, of Lafayette, California, said her daughter, M.C.,
then 8 months old, was hospitalized in April and treated for botulism
after being fed ByHeart formula in hopes of helping the baby sleep.
For months, neither mother had any idea where the infections could have
originated. Such illnesses in babies typically are caused by spores
spread in the environment or by contaminated honey.
Then ByHeart recalled all of its products nationwide on Nov. 11 in
connection with growing cases of infant botulism.
As soon as she heard it was ByHeart, Mazziotti said she thought: “This
cannot be a coincidence.”
ByHeart officials this week confirmed that laboratory tests of
previously unopened formula found that some samples were contaminated
with the type of bacteria that leads to infant botulism.
Marler said at least three other cases that predate the outbreak
involved babies who drank ByHeart and were treated for botulism,
according to their families. One consumed ByHeart formula in December
2024. The other two were sickened later in the spring, he said.
An official with the U.S. Centers for Disease Control and Prevention
said federal investigators were aware of reports of earlier illnesses
but that efforts are focused now on understanding the unusual surge of
dozens of infections documented since Aug. 1.
“That doesn’t mean that they’re not necessarily part of this,” said Dr.
Jennifer Cope, a CDC scientist leading the probe. “It’s just that right
now, we’re focusing on this large increase.”
Because so much time has passed and because parents of babies who got
sick earlier may not have recorded lot numbers of product or kept empty
cans of formula, “it will make it harder to definitively link them” to
the outbreak, Cope said.
Connolly said it feels like her daughter has been forgotten.
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This March 2025 photo provided by Amy Mazziotti shows Hank Mazziotti,
8 months, being treated for infant botulism in Los Angeles. (Amy
Mazziotti via AP)
 “What I want to know is why did the
cases beginning in August flag an investigation, but the cases that
began in March did not?” Connolly said.
Cope and other health officials said the strong signal connecting
ByHeart to infant botulism cases only became apparent in recent
weeks.
Before this outbreak, no powdered infant formula in the U.S. had
tested positive for the type of bacteria that leads to botulism,
California health officials said. The number of cases also were
within an expected range. A test of a can of open formula fed to a
sick baby in the spring did not detect the bacterium.
Then, beginning in August and through October, more cases were
identified on the East Coast involving a type of toxin rarely
detected in the region, officials said. More cases were seen in very
young infants and more cases involved ByHeart formula, which
accounts for less than 1 percent of infant formula sold in the U.S.
Earlier this month, after a sample from a can of ByHeart formula fed
to a sick infant tested positive for the germ that leads to illness,
officials notified the CDC, the U.S. Food and Drug Administration
and the public.
Less than 200 cases of infant botulism are reported in the U.S. each
year. The disease is caused when babies ingest spores that germinate
in the gut and produce a toxin. The bacterium that leads to illness
is ubiquitous in the environment, including soil and water, so the
source is often unknown.
Officials at the California Infant Botulism Treatment and Prevention
Program track reports of botulism and the distribution of the only
treatment for the illness, an IV medication called BabyBIG.
Outside food safety experts said the CDC should count earlier cases
as part of the outbreak if babies consumed ByHeart formula and were
treated for botulism.
“Absolutely, yes, they should be included,” said Frank Yiannas,
former deputy commissioner for food policy and response at the U.S.
Food and Drug Administration. “Why wouldn’t they be included?”
Sandra Eskin, chief executive of STOP Foodborne Illness, an advocacy
group, agreed.
“This outbreak is traumatic for parents,” she said. “They may have
fed their newborns and infants a product they assumed was safe. And
now they’re dealing with hospitalization and serious illness of
their babies.”
Connolly and Mazziotti said their babies are improving, though they
still have some lingering effects. Botulism causes symptoms that
include constipation, poor feeding, head and limb weakness and other
problems.
After months of uncertainty about the potential cause of the
infection, Connolly said she “became completely obsessed” with the
link to ByHeart formula. Now, she just wants answers.
“We deserve to know the data that can help us understand how our
babies got sick,” she said.
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