Next-generation baby nutrition company ByHeart announces it is voluntarily recalling two batches of infant formula following a notification from the U.S. Food and Drug Administration of a broader ongoing investigation regarding an infant botulism outbreak.

The FDA has not identified a direct link between any infant formula and these cases, and there is no historical precedent of infant formula causing infant botulism. ByHeart says it is taking a proactive step to remove any potential risk from the market and ensure safety for infants.

ByHeart was notified by the FDA on November 7th of an estimated 83 cases of infant botulism that were reported nationwide since August 2025. The FDA has noted that 13 infants did consume ByHeart brand formula at some point. The bacteria that causes botulism is uncommon in dairy products or infant formula, and is naturally occurring in soil, certain vegetables, and dust.

The recall applies to two batches of formula distributed nationwide.

Batch Code: 251261P2, Use by: 01 Dec 2026
Batch Code: 251131P2, Use by: 01 Dec 2026
UPC: 5004496800

No other ByHeart infant formula batches are subject to this recall.

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Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants which occurs whenClostridium botulinumspores are ingested and colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest.

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