Breaking News: Botulism Outbreak Spreads to All ByHeart Products, Sickening Over 50 Babies
At least 51 infants in 19 states have fallen ill with botulism, a potentially life-threatening condition, after consuming ByHeart baby formula. The US Centers for Disease Control and Prevention (CDC) has expanded the case definition to include any infant exposed to ByHeart formula since its release in March 2022.
The outbreak has been linked to all ByHeart products, and the US Food and Drug Administration (FDA) has stated that investigators cannot rule out the possibility of contamination affecting all formula products ever made. The most recent illness was reported on December 1.
ByHeart baby formula was first recalled in November 2025, but the FDA has now expanded the investigation to include all products made since March 2022. No deaths have been reported in the outbreak.
The CDC and FDA are working together to investigate the source of the contamination and to inform the public about the risks associated with ByHeart formula. Parents and caregivers are advised to check their supplies and discard any ByHeart formula.
This is a developing story, and we will provide updates as more information becomes available.
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