On November 8, 2025, ByHeart announced that they have voluntarily recalled two batches of its Whole Nutrition Infant Formula due to a link to an increase in infant botulism cases, though a direct link has not yet been identified by the FDA. The recalled lot numbers are 206VABP/251261P2 and 206VABP/251131P2. On November 11, ByHeart expanded the recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide.

Our pediatricians are recommending that parents stop using the recalled formula, wash all items and surfaces that may have come into contact with it, and seek immediate medical care if their infant shows any symptoms of infant botulism.  

What to do:

• Stop use immediately. Do not use the recalled formula. Throw it away or return it to the place of purchase.
• Check the lot number on the bottom of the can. Recalled batches are:
  • 206VABP/251261P2
  • 206VABP/251131P2
  • All batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide.
• Clean everything. Wash all items and surfaces that may have touched the recalled formula with hot, soapy water or use a dishwasher.
• Monitor for symptoms. Seek immediate medical care if your infant shows any symptoms of infant botulism. Parents should be vigilant, as symptoms can take weeks to develop.  

Symptoms of infant botulism:

• Poor feeding or difficulty swallowing
• Loss of head control
• Decreased facial expression
• Constipation
• Drooping eyelid (ptosis)
• Sluggish pupils
• Low muscle tone or generalized weakness
• Weak or altered cry
• Difficulty sucking
• Difficulty breathing or respiratory arrest 

Recommended organic formula changes:

• Kendamil
• Similac bliss
• Bobbie

Our providers and clinicians are working diligently to stay up to date with information and updates provided by the FDA and CDC.  Please contact our offices if you have any further questions or concerns regarding the recall.  You may also read the latest updates from ByHeart here.