Created in 2007 by the Pennsylvania Office of Child Development and Early Learning (OCDEL), The Pennsylvania Key implements the work and supports the policies developed and managed by OCDEL. Learn More. >
Created in 2007 by the Pennsylvania Office of Child Development and Early Learning (OCDEL), The Pennsylvania Key implements the work and supports the policies developed and managed by OCDEL. Learn More. >The Pennsylvania Department of Health has issued a Health Alert Network announcement, Infant Botulism Outbreak Linked to Infant Formula.
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, and through retail stores nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, Sam’s Club, and others.
Infant botulism is a rare but potentially fatal paralytic illness that impacts babies less than one year old. Symptoms can include constipation, poor feeding, drooping eyelids, a weak cry, and progressive muscle weakness.
Healthcare providers (HCPs) should call the California Infant Botulism Treatment and Prevention Program (IBTPP) immediately at 510-231-7600 for consultation on a suspected case. Consultation is available 24/7. Treatment with botulism immune globulin, BabyBIG®, obtained from the California Department of Health, is recommended for all suspected cases of infant botulism.
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.
The Health Alert Network is part of the Pennsylvania Department of Health’s Public Health Emergency Preparedness and Response Program, established under a cooperative agreement with the U.S. Centers for Disease Control and Prevention (CDC).