December 11, 2025 — Health officials dramatically expanded an outbreak of botulism after concluding that all ByHeart Baby Formula ever made since 2022 might have been contaminated.
In an update, the FDA said it “cannot rule out the possibility that contamination might have affected all ByHeart formula products.”
That means babies could have been getting sick from ByHeart formula for several years before it was recalled in November 2025.
The expanded outbreak now includes all reports of infants who were diagnosed with botulism after consuming ByHeart Whole Nutrition Infant Formula at any time since it hit the market in March 2022.
Under the expanded criteria, ByHeart formula has been linked to 51 reports of infant botulism in 19 states between December 2023 and December 2025. All of the babies were hospitalized and survived.
Botulism can be deadly, so parents and caregivers should seek emergency medical attention for infants who develop symptoms of botulism. It can take up to 30 days for the symptoms to appear.
According to the CDC:
“Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control.”
ByHeart has been selling infant formula since March 2022, but the FDA said there were no reports of botulism until December 2023. The most recent illness was reported on December 1, 2025.
ByHeart has recalled all of its formula and it should no longer be in stores. The FDA said laboratory confirmation for some cases is still ongoing, so the case count may still continue to grow.
Do I Have a ByHeart Botulism Lawsuit?
The Schmidt Firm, PLLC is currently accepting ByHeart Botulism cases in all 50 states. If your baby got botulism from ByHeart Whole Nutrition Infant Formula at any time since 2022, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Baby Formula Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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