11/12/2025
IF YOU USE BY HEART FORMULA
Update: ALL lots of infant formula from ByHeart, in all sizes of cannisters and pouches, have been recalled.
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Since August, 15 cases of infant botulism in infants who consumed ByHeart brand infant formula have been reported to the Centers for Disease Control and Prevention (CDC) from 12 states. Nine of the cases have been confirmed by testing that showed botulinum toxin type A.
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FDA issued communications about a recall of all lots of infant formula from ByHeart, in all sizes of cannisters and pouches. The link to the recall, which includes photos of products, is: https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025.
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Infants should not be fed the recalled formula. If parents and caregivers still have ByHeart product, they should:
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take a photo or record the information on the bottom of the package.
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keep the container in a safe spot and be sure to label that product as DO NOT USE.
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If the child develops symptoms, the product might be needed for testing. If the child does not develop symptoms after 30 days, they should throw the containers out.
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NYSDOH is asking providers to maintain heightened suspicion for the possibility of infant botulism in any infant presenting with compatible symptoms who was fed ByHeart infant formula.
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Additionally, providers should ask which formula brand is fed to their infant patients, alert parents/guardians to the ByHeart recall, and ensure recalled formula is not used.
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Providers should report suspect botulism cases to the local health department of the patient’s county of residence immediately.
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