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¡No permitas que los gérmenes ganen esta temporada! ¡Protégete a ti y a tu familia!
La vacuna contra la influenza es tu mejor defensa contra la influenza y sus complicaciones. Además, ¡es un beneficio cubierto para los miembros de Texas Children's Health Plan! Aprende más
Call to action: Texas Children’s Health Plan (TCHP) would like to inform providers of an important public health issue from our partners at the Texas Department of State Health Services regarding infant botulism linked to powdered infant formula (and related formula recall).
ByHeart Powered Formula/ Infant botulism information
Multi-state outbreak of infant botulism linked to ByHeart powdered infant formula
12 states and case numbers: Arizona, California (2), Illinois (2), Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington.
As of November 11, 2025, this outbreak includes fifteen (15) infants with suspected or confirmed infant botulism.
All 15 infants were hospitalized and treated with BabyBIG® (Botulism Immune Globulin Intravenous medication). No deaths have been reported.
Patient/caregiver guidance when ByHeart formula was used:
Do not use any ByHeart Whole Nutrition infant formula. This includes formula sold in cans and single serve packets.
If possible, take a picture or record the lot number and best by date.
If you have leftover ByHeart powdered formula, label it "DO NOT USE" and keep it stored in a safe place for at least a month.
If your infant develops symptoms of infant botulism, your state health department may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.
Monitor for symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek medical care immediately if symptoms appear. Early intervention is critical.
Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.
Institutions, hospitals, clinical labs, and public health partners:
Do not use or distribute any of the recalled ByHeart Whole Nutrition infant formula. Remove it from inventory and inform relevant staff.
Clean and sanitize feeding areas and equipment that may have been exposed.
Ensure clinical labs and pathology services are aware that infant botulism is a reportable condition and laboratory confirmation is critical for case investigation; ensure timely specimen collection and consultation with the state or local health departments for information on specimen collection and confirmatory testing.
Participate in trace-back, leftover product collection, and laboratory testing as requested by state health departments, CDC and the FDA.
Next Steps
CDC and FDA, along with state and local health departments, are working to determine the contamination source and to issue further guidance as information becomes available. For clinicians and health‐care systems, preparedness means:
recognizing the signs and symptoms of infant botulism promptly
having protocols in place for consultation and treatment
ensuring awareness of case notification procedures
providing caregivers with clear instructions when feeding concerns arise
Reporting instructions
Please report suspect cases immediately to your state and local health department.
For health departments, CDC’s Division of Foodborne, Waterborne, and Environmental Diseases at botsurveillance@cdc.gov is available to answer questions and receive case reports.
For public health and investigation inquiries, please contact the CDC Emergency Operations Center at 770-488-7100 (after hours) or your state or local health department.
