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FDA Recalls ByHeart Infant Formula Amid Botulism Outbreak

1/26/2026

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Summary

Story summary

The Food and Drug Administration (FDA) linked a botulism outbreak in 51 infants to ByHeart's Whole Nutrition Infant Formula and recalled all products.
Testing detected Clostridium botulinum in the formula and whole milk powder from an unidentified supplier.
No cases have been reported since December 10, and FDA warned retailers like Target to stop selling recalled products.
ByHeart will revise testing and manufacturing after the Operation Stork Speed launch.

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Story summary

The Food and Drug Administration (FDA) linked a botulism outbreak in 51 infants to ByHeart's Whole Nutrition Infant Formula and recalled all products.
Testing detected Clostridium botulinum in the formula and whole milk powder from an unidentified supplier.
No cases have been reported since December 10, and FDA warned retailers like Target to stop selling recalled products.
ByHeart will revise testing and manufacturing after the Operation Stork Speed launch.