November 14, 2025
A multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula has been identified in the United States. As of November 11, 2025, Idaho has no cases associated with the outbreak, but 15 infants with suspected or confirmed infant botulism have been reported by 12 other states. All 15 infants were hospitalized and treated with BabyBIG® (Botulism Immune Globulin Intravenous medication). No deaths have been reported.
Review of data among the 84 infants receiving BabyBIG® treatment in the U.S. since August 1, 2025, revealed that 15 had consumed ByHeart Whole Nutrition infant formula, although ByHeart represents only about 1% of all infant formula sales in the U.S. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in an open can of ByHeart infant formula that was fed to an infant with infant botulism. Additional testing is underway, and results are expected in the coming weeks.
On November 11, ByHeart Inc. recalled all ByHeart Whole Nutrition infant formula products. CDC and FDA recommend that parents and caregivers immediately stop use of all ByHeart Whole Nutrition infant formula, including cans and single serve packets.
Recomendaciones para los médicos
Consider infant botulism a clinical diagnosis in any infant presenting with unexplained weakness, poor feeding, decreased head control, or difficulty swallowing — especially if the infant has consumed ByHeart formula.
If you suspect infant botulism:
- Do no wait for laboratory confirmation to initiate case management. Early recognition and treatment are critical.
- Contact public health officials= During business hours, contact Central District Health at (208) 327-8625. After hours and weekends, call the Idaho State Communications line at 800-632-8000. A public health official will be notified. · For clinical consultation and to obtain BabyBIG®, contact the Infant Botulism Treatment & Prevention Program (IBTPP) at 510-231-7600. Consultation is available 24 hours a day, 7 days a week.
- If clinical consultation supports infant botulism, begin treatment with BabyBIG® without delay. Do not wait for laboratory confirmation.
Infant botulism occurs when an infant ingests spores the bacteria Clostridium botulinum, which then grows in the large intestine and produces toxin that blocks the neuromuscular junction by inhibiting the release of acetylcholine. Initial signs and symptoms often include constipation, difficulty feeding (difficulty sucking or swallowing), loss of head control, weak facial expression, and reduced muscle tone. Without prompt recognition and treatment, descending paralysis may progress and involve the respiratory muscles, potentially leading to life-threatening respiratory failure. The time from ingestion to symptom presentation can be up to 30 days.
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) | FDA
Infant Botulism Outbreak Linked to Infant Formula, November 2025 | Botulism | CDC
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