ByHeart baby formula from all lots may be contaminated with botulism
bacteria, tests show
[November 26, 2025]
By JONEL ALECCIA
Tests of ByHeart infant formula tied to a botulism outbreak that has
sickened dozens of babies showed that all of the company's products may
have been contaminated.
Laboratory tests of 36 samples of formula from three different lots
showed that five samples contained the type of bacteria that can lead to
the rare and potentially deadly illness, the company said Monday on its
website.
“Based on these results, we cannot rule out the risk that all ByHeart
formula across all product lots may have been contaminated,” the company
wrote.
At least 31 babies in 15 states who consumed ByHeart formula have been
sickened in the outbreak that began in August, according to federal and
state health officials. In addition, other infants who drank ByHeart
formula were treated for botulism in earlier months, as far back as
November 2024, although they are not counted in the outbreak, officials
said.
Clostridium botulinum type A, the type of bacteria detected, can be
unevenly distributed in powdered formula. Not all babies who ingest it
will become ill, though all infants under age 1 are at risk, medical
experts said.
ByHeart recalled all of its formula nationwide on Nov. 11. However, some
product has remained on store shelves despite the recall, according to
state officials and the U.S. Food and Drug Administration.
Parents and caregivers should stop feeding the formula to babies
immediately and monitor the children for symptoms, which can take up to
30 days to appear.
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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)
 Infant botulism occurs when babies
ingest spores that germinate in their intestine and produce a toxin.
Symptoms include constipation, difficulty sucking or feeding,
drooping eyelids, flat facial expression and weakness in the arms,
legs and head. The illness is a medical emergency and requires
immediate treatment.
At least 107 babies nationwide have been treated for botulism with
an IV medication known as BabyBIG since Aug. 1, health officials
said. In a typical year, less than 200 infants are treated for the
illness.
To report an illness tied to the outbreak, contact an FDA consumer
complaint coordinator or fill out an online MedWatch form.
Consumers who bought ByHeart on the company's website on or after
Aug. 1 can receive a full refund, an expansion of its previous
policy, the company said.
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