Gray Ritter Graham Investigating Reports of Infant Illness Potentially Linked to ByHeart Infant Formula
Gray Ritter Graham is monitoring and investigating reports of infant illness potentially associated with ByHeart Whole Nutrition Infant Formula following a nationwide recall issued in November 2025. The recall includes all ByHeart formula products, including cans and single-serve sticks.
Infant Illnesses Reported
Public health agencies have reported a growing number of infants receiving treatment for infant botulism since August 2025. As of November 19, 2025, at least 31 infants across 15 states have suspected or confirmed infant botulism with confirmed exposure to ByHeart formula. All identified infants required hospitalization. Public health officials anticipate these numbers may continue to rise as investigations and testing progress.
Further updates are expected from federal and state health authorities as the investigation progresses.
About Infant Botulism
Infant botulism is a rare but serious illness caused when babies ingest Clostridium botulinum spores, which can germinate in the intestines and produce botulinum toxin. Botulinum spores can enter food products, such as formula, if introduced during sourcing, manufacturing, or handling.
Infants under twelve months old are particularly vulnerable because their intestinal flora and immune defenses are still developing.
Symptoms may begin subtly and progress over several days or weeks. They can include:
- Constipation, often the earliest sign
- Poor feeding, weak sucking, or trouble swallowing
- A weak or altered cry
- Reduced facial expression or diminished alertness
- Poor head control (“floppiness”)
- Generalized muscle weakness, which may start in the face
- Breathing difficulties in more advanced cases
General Information for Parents and Caregivers
Families who have used ByHeart formula should be aware of the recall and the ongoing public health investigation. Public health agencies have advised that recalled formula should not be used and that product containers and identifying information should be retained for reference. Parents and caregivers may wish to remain aware of any unusual changes in an infant’s feeding, behavior, or muscle tone and consult a healthcare provider with any concerns.
Additional information and updates are expected from the FDA, CDC, and state health departments as the investigation continues.
GRG’s Ongoing Investigation
Gray Ritter Graham is currently investigating this issue and reviewing reports of infant illness potentially connected to ByHeart formula. We are evaluating cases for further review and are available to discuss concerns with families who believe their child may have been affected. Our attorneys can help assess relevant information and ensure important materials are preserved as the public health investigation develops.
For more information, please contact us at (314) 241-5620, or fill out our contact form.