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ByHeart infant formula recalled after botulism sickens 13 children nationwide
The FDA and CDC confirmed a botulism outbreak linked to ByHeart Whole Nutrition Infant Formula, resulting in the hospitalization of 13 infants across 10 states, including one in Washington. Parents are urged to immediately dispose of the recalled formula and seek medical attention if their infant shows symptoms like poor feeding or loss of head control.
SEATTLE - ByHeart Whole Nutrition Infant Formula is recalling its product after more than a dozen children were hospitalized with botulism.
At local stores, ByHeart baby formula is still on the shelves. FOX 13 Seattle checked several cans, finding best-by dates for November and January, but none from the recalled month of December.
On its website, ByHeart announced a "voluntary recall" after unopened cans of formula tested positive for botulism.
Botulism in baby formula
What we know:
Over the weekend, the FDA and CDC confirmed a botulism outbreak, with at least 83 cases of infant botulism reported nationwide since August 2025. One of those cases was here in Washington, where the child had to be hospitalized.
"Unfortunately, it’s not just a recall. There are 13 infants sickened, but most likely all still in the hospital undergoing treatment for botulism," said food safety attorney Bill Marler.
So far, no deaths have been reported.
The CDC says illnesses began between mid-August and November in infants as young as 16 days old and up to under 6 months.
"It’s pretty clear that the FDA and CDC in a sense have their culprit," Marler said.
Dig deeper:
Botulism is rare, but extremely serious. Marler worries the number of sick infants could still grow, since symptoms can take up to seven weeks to appear after exposure.
"This kind of botulism, botulism A, is what impacts children, and you see it a lot of times in honey. That’s why parents are warned not to feed their children under the age of 1 unpasteurized honey. But like all kinds of botulism, it’s very deadly," said Marler.
What you can do:
The CDC urges parents to:
- Throw away or return any recalled ByHeart formula.
- Wash all bottles, nipples, and surfaces the formula may have touched.
- Seek medical care immediately if your baby shows symptoms such as poor feeding, loss of head control, difficulty swallowing, decreased facial expressions, weak muscles, or "floppy baby syndrome."
While botulism can be treated, there’s no early detection test, meaning symptoms are the first sign something’s wrong.
Big picture view:
Marler also notes this isn’t ByHeart’s first issue with regulators.
"They had a recall in 2022 linked to corynebacteria, which is also a deadly pathogen that can be found in baby formula. And they also had a warning letter for producing food under unsanitary conditions," he said.
The Washington State Department of Health says WIC users are not affected by the recall, since ByHeart is not one of its approved brands.
Parents who have fed their infants ByHeart formula are urged to monitor for symptoms and contact a doctor if anything seems off.
"I just cannot imagine a parent going through this or being worried that they fed their child something," Marler said.
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The Source: Information in this story comes from original reporting by FOX 13 Seattle reporter Alejandra Guzman.