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Nationwide ByHeart Formula Recall Due to Botulism Outbreak

12/12/2025

Summary

Story summary

A nationwide recall of ByHeart baby formula has been issued due to an outbreak of infant botulism linked to the product, affecting all items made since March 2022.
The U.S. Food and Drug Administration (FDA) has confirmed at least 51 cases across 19 states, with all affected infants having consumed ByHeart formula.
The Centers for Disease Control and Prevention (CDC) has expanded its case definition to include any infant exposed to the formula since its release.
Although no fatalities have been reported, symptoms can result in severe health complications.
ByHeart is cooperating with federal investigations, while families of affected infants have filed lawsuits alleging negligence.

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Story summary

A nationwide recall of ByHeart baby formula has been issued due to an outbreak of infant botulism linked to the product, affecting all items made since March 2022.
The U.S. Food and Drug Administration (FDA) has confirmed at least 51 cases across 19 states, with all affected infants having consumed ByHeart formula.
The Centers for Disease Control and Prevention (CDC) has expanded its case definition to include any infant exposed to the formula since its release.
Although no fatalities have been reported, symptoms can result in severe health complications.
ByHeart is cooperating with federal investigations, while families of affected infants have filed lawsuits alleging negligence.