Infant Botulism Outbreak Linked to Recalled Infant Formula


November 18, 2025

Dear Colleague:
This letter provides information on an outbreak of infant botulism linked to ByHeart powdered infant formula. At this time, there are no cases of infant botulism from

Background
The Centers for Disease Control and Prevention (CDC) and public health officials in several states, the Infant Botulism Treatment and Prevention Program, and the FDA are investigating a multistate outbreak of infant botulism linked to recalled infant formula. Epidemiologic data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum and is making infants sick.

As of November 14, 23 infants with suspected or confirmed infant botulism have been reported from 13 states: Arizona, California (2), Illinois (2), Kentucky, Michigan, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington. All 23 infants were hospitalized and treated with BabyBIG® (Botulism Immune Globulin Intravenous medication). No deaths have been reported.

CDC and FDA recommend that parents and caregivers immediately stop use of all ByHeart Whole Nutrition infant formula, including cans and single serve packets. 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. On November 11, ByHeart Inc. recalled all ByHeart Whole Nutrition infant formula products. FDA does not anticipate any formula shortages as a result of this outbreak.

Infant botulism occurs when an infant ingests spores from a type of bacteria called 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.

Recommendations for Clinicians
Consider infant botulism as 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.

When a case is suspected:

  • Immediately report all suspected cases immediately to your local health department.
  • Arrange for consultation with the Infant Botulism Treatment & Prevention Program (IBTPP) at 510-231-7600 for evaluation and treatment guidance. 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 to initiate case management. Early recognition and treatment are critical.

Your local health department will discuss options for public health testing. Laboratory personnel must be alerted if botulism is suspected so they can take appropriate precautions. Botulinum toxins are extremely poisonous and exposure to the toxin is the primary laboratory hazard.


Recommendations for Institutions, Hospitals, and Clinical Laboratories

  • 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.
  • Infant botulism is an immediately reportable condition. It is important to quickly reach out to VDH when a case is suspected to coordinate on timely collection of clinical specimens and processes for confirmatory testing.
  • Participate in trace-back efforts, leftover product collection, and laboratory testing as requested by state health departments, CDC, and FDA.

Resources

Thank you for your partnership in keeping Virginians safe and healthy.

Sincerely,

Karen Shelton, MD

State Health Commissioner