11/14/2025
Infant Botulism Outbreak Linked to Infant Formula, November 2025
The Pennsylvania Department of Health has issued a Health Alert Network announcement regarding an Infant Botulism Outbreak Linked to Infant Formula. https://www.pakeys.org/health-alert-network-announcement-infant-botulism-outbreak-linked-to-infant-forumula/
On November 11, 2025, ByHeart, Inc. recalled all lots of ByHeart Whole Nutrition Infant Formula in response to the U.S. Food and Drug Administration’s (FDA’s) ongoing investigation into a recent outbreak of infant botulism.
According to the company’s website, ByHeart Whole Nutrition Infant Formula was sold through its website, ByHeart.com, as well as through retail stores nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, Sam's Club, and others.
Infant botulism is a reportable disease in PA; all suspected cases must be reported to the Pennsylvania Department of Health (DOH) at 1-877-PA-HEALTH or their local health department. For additional details, please see the Health Alert Network announcement, Infant Botulism Outbreak Linked to Infant Formula.
For more information:
What should I know about recalled baby formula? - Healthy Children: https://www.healthychildren.org/English/tips-tools/ask-the-pediatrician/Pages/What-should-I-know-about-the-infant-formula-recall.aspx
CDC: https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/index.html
Cleveland Clinic: https://my.clevelandclinic.org/health/diseases/infant-botulism
The Pennsylvania Department of Health has issued a Health Alert Network announcement, Infant Botulism Outbreak Linked to Infant Formula.