As infant botulism cases climb to 31, recalled ByHeart baby formula is
still on some store shelves
[November 20, 2025]
By JONEL ALECCIA
As cases of potentially deadly botulism in babies who drank ByHeart
infant formula continue to grow, state officials say they are still
finding the recalled product on some store shelves.
Meanwhile the company reported late Wednesday that laboratory tests
confirmed that some samples of formula were contaminated with the type
of bacteria that has sickened more than 30 babies in the outbreak.
Tests by an independent food safety laboratory found Clostridium
botulinum, a bacterium that produces toxins that can lead to potentially
life threatening illness in babies younger than 1, the company said on
its website. ByHeart officials said they notified the U.S. Food and Drug
Administration of the findings but did not specify how many samples were
tested or how many were positive.
“We are working to investigate the facts, conduct ongoing testing to
identify the source, and ensure this does not happen to families again,”
ByHeart said on its website.
The FDA did not immediately respond to questions about the findings.
The lab results come as investigators in at least three states found
ByHeart formula still for sale even after the New York-based company
recalled all products nationwide, officials told The Associated Press.
At least 31 babies in 15 states who drank ByHeart formula have been
hospitalized and treated for infantile botulism since August, federal
health officials said Wednesday. They range in age from about 2 weeks to
about 6 months, with the most recent case reported on Nov. 13.
No deaths have been reported.
In Oregon, nine of more than 150 stores checked still had the formula on
shelves this week, a state agriculture official said. In Minnesota,
investigators conducted 119 checks between Nov. 13 and Nov. 17 and
removed recalled products from sale at four sites, an agriculture
department official said. An Arizona health official also said they
found the product available.
Businesses and consumers should remain alert, Minnesota officials said
in a statement. “No affected product should be sold or consumed,” they
wrote.
Investigators with the U.S. Food and Drug Administration conducted
inspections at ByHeart manufacturing plants in Allerton, Iowa, and
Portland, Oregon. No results from the inspections have been reported.
California officials previously confirmed the germ that can lead to
illness in an open can of ByHeart formula fed to a baby who fell ill.
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ByHeart infant formula has been removed from shelves of a Walmart
store in Temecula, Calif., on Nov. 16, 2025. (AP Photo/JoNel Aleccia)
 Infant botulism, which can cause
paralysis and death, is caused by a type of bacteria that forms
spores that germinate in a baby's gut and produce a toxin.
Symptoms can take up to 30 days to develop and include constipation,
poor feeding, a weak cry, drooping eyelids or a flat facial
expression. Babies can develop weakness in their limbs and head and
may feel “floppy.” They can have trouble swallowing or breathing.
ByHeart had been manufacturing about 200,000 cans of formula per
month. It was sold online or at retail stores such as Target and
Walmart. A Walmart spokesperson said the company swiftly issued a
restriction that prevented sale of the formula, removed the product
from stores and notified consumers who had bought it. Customers can
visit any store for a refund of the formula, which sold for about
$42 per can.
Federal and state health officials are concerned that some parents
and caregivers may still have ByHeart products in their homes. They
are advising consumers to stop using the product — including formula
in cans and any single-serve sticks. They also suggest marking it
“DO NOT USE” and keeping it for at least a month in case a baby
develops symptoms. In that case, the formula would need to be
tested.
The California health department operates the Infant Botulism
Treatment and Prevention Program, which tracks cases and distributes
treatment for the disease. Officials there have launched a public
hotline at 833-398-2022, which is staffed with health officials from
7 a.m. to 11 p.m. Pacific Standard Time.
The new hotline was created after calls from hundreds of parents and
caregivers flooded a different, longstanding hotline for doctors to
discuss suspected infant botulism cases, officials said.
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