Emerging Infectious Threats: Neonatal Sepsis and the ByHeart Formula Recall

ByHeart formula has been linked to 31 affected infants across 15 states as of Nov. 20, 2025; all were hospitalized and no deaths have been reported.

Neonatal sepsis risk stratification remains based on maternal intrapartum fever, prolonged rupture of membranes, maternal GBS colonization, abnormal newborn examination, and validated early-onset sepsis calculators or local sepsis pathways.

Poor feeding, loss of head control, weak cry, or decreased facial expression developing over days to weeks should prompt immediate evaluation for infant botulism. Symptomatic infants require hospitalization for respiratory monitoring, early antitoxin consultation, and public health notification to enable testing and exposure tracing.

It's important to isolate any recalled formula and document lot numbers and feeding histories. Cohort or observe exposed infants, reinforce hand hygiene and strict formula-handling (no pooling or sharing), and clean feeding equipment and surfaces with hot, soapy water or a dishwasher when appropriate. Perform daily focused examinations of exposed infants and minimize additional exposures while preserving routine neonatal care.

Tell caregivers what is known about the exposure, the signs to watch for (poor feeding, decreased tone, breathing changes), when to seek urgent care, and how reporting and testing will proceed. Immediate clinical priorities are identifying exposed infants, frequent monitoring for neurologic or feeding changes, early escalation of respiratory support if needed, and coordination with public health for testing and contact tracing.

Key Takeaways:

• Independent testing found Clostridium botulinum in some ByHeart products; 31 infants affected across 15 states.
• Infants who consumed recalled ByHeart formula — monitor exposed infants for poor feeding, decreased tone, or respiratory difficulty.
• Prioritize identification of exposed infants, frequent outpatient or inpatient monitoring for neurologic/feeding signs, escalate respiratory support as required, and notify public health for testing and tracing.