Botulism found in ByHeart formula, company confirms; Second WA infant sick
Nov 20, 2025, 7:17 AM
A child receives treatment at a hospital. (Photo: Ahmad Hasaballah, Getty Images)
(Photo: Ahmad Hasaballah, Getty Images)
Cases of potentially deadly botulism in babies who drank ByHeart infant formula continue to grow nationwide, including right here in Washington.
The company reported late Wednesday that laboratory tests confirmed that some formula samples were contaminated with the type of bacteria that has sickened more than 30 babies in the outbreak.
“We have just learned that [our] tests identified Clostridium botulinum in some samples of ByHeart formula,” the company stated. “We immediately notified the FDA of those findings, and we are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again.
“We continue to urge parents and caregivers to stop using ByHeart formula immediately, monitor your child for symptoms of infant botulism, and seek medical care immediately if they develop symptoms,” the company continued in its statement.
The CDC said there are now 31 cases of infant botulism in 15 states linked to ByHeart baby formula in the U.S., including two cases in Washington: one in Pierce County and one in Lewis County.
“It can kill,” attorney Bill Marler, who represents the family of the Pierce County baby and a dozen other families whose babies were sickened in the outbreak, said. “The botulism spore gets into their large intestine and essentially manufactures the most deadly toxin known to man, botulism.”
Fortunately, he said there is a very effective anti-toxin. None of the babies identified by the CDC in the outbreak has died.
“All of them have been hospitalized. Most have gotten out or will be getting out soon,” Marler said. “Most were in pediatric intensive care units for a week to two weeks on this anti-toxin. Many of them are on feeding tubes.”
It’s unclear how the formula became contaminated, but Marler, who has been involved in food safety cases for three decades, said it likely happened either at the plant or by an ingredient containing botulism that was brought into the plant.
Either way, he said, “Botulism spores shouldn’t be in food, and they shouldn’t be in infant formula.”
ByHeart recalls products amid cases of infant botulism
ByHeart officials told The Associated Press they voluntarily recalled their products “in close cooperation” with the FDA, “despite the fact that no unopened ByHeart product has tested positive” for the spores or toxin that cause infant botulism.
Photos of ByHeart baby formula products. (Photos courtesy of KIRO 7)
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Symptoms of infant botulism
The CDC said parents and caregivers should immediately stop using ByHeart Whole Nutrition infant formula, and Marler said they should be aware of the symptoms of infant botulism. Those can include constipation and fussiness, and progress to changes in a baby’s face, such as droopy eyelids and difficulty sucking bottles.
“Then they can develop what’s known as floppy baby syndrome,” Marler said.
He added that the toxin attacks the muscles, “and if not treated, it can impact the diaphragm and breathing, and that’s what unfortunately can kill.”
Marler said that the families he is working with describe the experience as devastating and scary.
Marler’s firm, Marler Clark, has filed three complaints against ByHeart. He said the families are seeking more than compensation.
“Hopefully we’re going to get to the bottom of exactly how this happened and what we can do to prevent it from happening again,” Marler said.
Contributing: The Associated Press
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