11/12/2025
Please read this post if you are using this brand of formula !! Thanks Effingham County Health Department !
RECALL UPDATE: All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks.
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
Do not use recalled ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing.
All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks.
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
What to Do:
Please stop using these recalled products and return or dispose of the product.
Clean any bottles or surfaces that may have come into contact with the formula.
If your infant has consumed this product and isn’t feeling well, contact your healthcare provider for guidance.
FDA is expanding its recommendation to include all ByHeart infant formula products due to the number of ill infants reported to have consumed this product, the identification of additional lot codes, the identification of new cases of suspected infant botulism, and the preliminary positive sample collected and tested by the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP).
ByHeart infant formula products makes up less than 1% of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.
Symptoms of Infant botulism
Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.
Stores affected
ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
Status
Ongoing
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025