The FDA Just Expanded a Multi-State Recall on Baby Formula, and Investigations Are Still Ongoing
ByHeart Whole Nutrition Infant Formula products may have links to infant botulism.
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If there’s a baby in your life, please listen closely: The U.S. Food and Drug Administration (FDA) has expanded a recall of ByHeart Whole Nutrition Infant Formula products to include all infant formula products made and marketed by the company following a multi-state outbreak of infant botulism.
In an announcement about the expansion posted online on Tuesday, November 11, the FDA said the move was being made in response to the growing number of confirmed and suspected cases of infant botulism linked to ByHeart Whole Nutrition Infant Formula products, as well as the identification of more lot codes and preliminary positive testing of samples collected by the California Department of Public Health’s Infant Botulism Treatment and Prevention Program.
Here’s everything you need to know about the recall right now:
Photo courtesy of U.S. Food & Drug Administration
Which infant formula is being recalled?
As of November 11, 2025, all ByHeart Whole Nutrition Infant Formula products, including all formula sold nationwide in cans as well as in single-serve sticks, are now subject to recall. ByHeart Whole Nutrition Infant Formula is carried by online retailers and major retail stores across the U.S.
The formula recall expansion follows an initial announcement on November 8, 2025, that California Department of Public Health testing had detected the presence of a botulinum-toxin-associated bacteria in a can of ByHeart infant formula (lot 206VABP/251131P2) that had been fed to an infant who became sick with botulism.
“Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants,” the FDA says.
Photo courtesy of U.S. Food & Drug Administration
Why is the formula being recalled?
Testing has indicated that ByHeart Whole Nutrition infant formula may be contaminated with Clostridium botulinum. That bacteria has been implicated as the likely cause of infant illness in several areas of the country.
So far, 15 infants across 12 states are either suspected or confirmed to have been sickened by ByHeart Whole Nutrition Infant Formula. All 15 infants have been hospitalized. As of November 10, none have died. Most of the affected infants range in age between 16 and 157 days, with an even gender split, and experienced the onset of symptoms between August 9 and November 10, 2025.
The illnesses were connected to a number of different lots of the formula. States in which illnesses have been reported, as of November 10, are Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
Further investigation, including into the origin of the contamination, is underway, and the recall is currently listed as “ongoing.”
What are symptoms of infant botulism?
Symptoms of infant botulism include constipation, difficulty feeding, decreased facial expression and loss of head control, as well as difficulty swallowing. These symptoms, which can take as long as several weeks to appear following consumption of a contaminated product, can lead to trouble breathing and respiratory arrest.
Because infant botulism can be fatal, parents are urged to take immediate action and seek medical attention right away if their child has consumed ByHeart Whole Nutrition Infant Formula and shows any of these symptoms.
What should you do if you have recalled ByHeart infant formula products?
For starters, immediately stop using ByHeart infant formula — do not feed it to your child. If your child has consumed ByHeart formula and is displaying any of the above symptoms of infant botulism, which can be fatal, you are urged to seek immediate medical attention. If your child has consumed ByHeart formula but is not showing any symptoms of infant botulism, monitor them closely, and if they develop symptoms, seek medical attention.
Those who have ByHeart infant formula in their homes are urged to take a photo of and/or write down the information on the bottom of the container. Rather than throw the container away, however, the FDA is asking parents and caregivers to clearly label it “DO NOT USE” and store it in a safe spot for 30 days.
“If your child develops symptoms, your state health department might want to collect your formula container for testing,” the agency explains. "If your child does not develop symptoms after 30 days, throw your containers out.”
Does the recall of ByHeart infant formula mean there will be a broader formula shortage?
No worries on that front. Because ByHeart produces less than one percent of all the infant formula sold and consumed across the U.S., this outbreak “does not create shortage concerns of infant formula for parents and caregivers,” the FDA says.
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