11/13/2025
RECALL INFORMATION—ByHeart Infant Formula ❗️
All ByHeart infant formula products have been voluntarily recalled following reports of infant botulism in 15 babies across 12 states, including two cases in Texas. The Food and Drug Administration (FDA) and company officials are urging families to stop using all ByHeart formula immediately.
The affected infants ranged in age from 16 to 157 days old. While no deaths have been reported, several infants have required hospitalization.
Steven A. Abrams, M.D., FAAP, former chair of the AAP Committee on Nutrition, emphasized that ByHeart represents only about 1% of the U.S. formula market and that the overall formula supply remains safe and available.
Products Included in the Recall
The voluntary recall applies to all ByHeart infant formula products, including:
Cans
Single-serve sticks
Samples distributed through hospitals, clinics, or directly to consumers
What Parents Should Do
If you still have the formula in your home, you should:
Take a photo or record the information on the bottom of the package.
Keep the container in a safe spot and be sure to label that product as DO NOT USE.
If your child develops symptoms your state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out.
Wash any items or surfaces that may have come into contact with the recalled formula using hot, soapy water or a dishwasher.
Parents can find tips for choosing a safe baby formula on HealthyChildren.org. ByHeart has also posted guidance for switching formulas.
Watch for Symptoms of Infant Botulism
Infant botulism can be life-threatening. Families should contact a pediatrician immediately if their baby shows any of these signs or symptoms:
Constipation
Poor feeding
Ptosis (drooping eyelid)
Sluggish pupils
Flattened facial expression
Diminished suck and gag reflexes
Weak or altered cry
Respiratory difficulty or respiratory arrest
While no unopened cans have tested positive for Clostridium botulinum, one previously opened sample was found to contain the bacteria. Investigations remain ongoing.
The Texas Pediatric Society will continue to monitor this recall and provide updates as new information becomes available. We will share developments on our website and in future editions of our TPS E-News to help practices stay informed and support families effectively.
For additional details and official updates, visit:
American Academy of Pediatrics – Botulism Information (HealthyChildren.org)
Centers for Disease Control and Prevention – Infant Formula Recall Investigation
U.S. Food & Drug Administration – Outbreak Investigation: Infant Botulism and ByHeart Formula Recall
AAP Redbook Resource—Infant Botulism Outbreak Linked to Infant Formula