Washington, D.C.- The Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), and state and local health departments are investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. As of November 19, 2025, 31 cases of suspected or confirmed infant botulism have been reported across 15 states. All affected infants were hospitalized and treated with BabyBIG®, a botulism antitoxin. No deaths have been reported.
Nationwide Recall Issued
ByHeart Inc. has voluntarily recalled all lots of its Whole Nutrition Infant Formula, including cans and single-serve “Anywhere Pack” packets, due to potential contamination with Clostridium botulinum, the bacterium that causes botulism. Parents and caregivers are urged to immediately stop using any ByHeart formula products.
The CDC reports that 40% of formula-fed infants treated for botulism during this outbreak had consumed ByHeart formula. The illness has been reported in the following states: Arizona (3), California (4), Idaho (1), Illinois (2), Kentucky (1), Maine (1), Michigan (1), Minnesota (2), North Carolina (2), New Jersey (1), Oregon (3), Pennsylvania (1), Rhode Island (1), Texas (6), and Washington (2). No cases have been reported in West Virginia at this time.
For full details on the recall and outbreak, visit the CDC’s outbreak page and the FDA’s investigation summary.
What Is Infant Botulism?
Infant botulism occurs when Clostridium botulinum spores are ingested and colonize the infant’s intestines, producing a neurotoxin. Symptoms may appear up to 30 days after exposure and include:
- Constipation
- Poor feeding or weak suck
- Weak or altered cry
- Loss of head control
- Diminished facial expression
If untreated, the illness can progress to life-threatening respiratory failure. Early recognition and treatment are critical.
Guidance for Healthcare Providers
The West Virginia Bureau for Public Health (BPH) urges clinicians to consider infant botulism in any infant presenting with unexplained weakness, poor feeding, or decreased head control—especially if the infant consumed ByHeart formula in the past 30 days.
If botulism is suspected:
- Contact the Infant Botulism Treatment and Prevention Program (IBTPP) at 510-231-7600 for a free consultation. BabyBIG® will be released if clinical findings support the diagnosis.
- Report suspected cases immediately to the local health department.
- Collect stool or enema specimens before administering BabyBIG®.
- Do not wait for lab confirmation to begin treatment.
For specimen collection and shipping protocols, contact the West Virginia Office of Laboratory Services Bioterrorism Laboratory at 304-205-8917.
Reporting Requirements
Infant botulism is a Category I reportable disease in West Virginia. All suspected or confirmed cases must be reported immediately to the local health department in the patient’s county of residence.
For more information, view the full West Virginia Health Advisory #232 or contact the Office of Epidemiology and Prevention Services.
Stay informed. Stay safe.
