The U.S. Centers for Disease Control and Prevention (CDC) is alerting medical and public health partners to a multistate outbreak of infant botulism associated with ByHeart powdered infant formula. This advisory provides updated epidemiologic information, guidance for early case identification, and critical actions for clinicians, hospitals, and public health agencies.
CDC has identified 15 infants with suspected or confirmed infant botulism across 12 states, all of whom required hospitalization and treatment with BabyBIG® (Botulism Immune Globulin Intravenous). While no deaths have been reported, new national data reveal a disproportionate number of illnesses among infants who consumed ByHeart Whole Nutrition formula, prompting an immediate nationwide recall of all ByHeart Whole Nutrition products on November 11. Neither CDC nor FDA has identified safety concerns with other formula brands at this time.
Infant botulism occurs when Clostridium botulinum spores colonize an infant’s digestive tract and produce toxin, leading to symptoms such as constipation, poor feeding, decreased head control, weak facial expression, and reduced muscle tone. Without early recognition and treatment, the illness can progress to life-threatening respiratory failure. Symptoms may appear up to 30 days after exposure.
Clinicians are urged to consider infant botulism in any infant presenting with unexplained weakness, feeding difficulty, or decreased muscle tone—particularly if ByHeart formula was consumed. CDC emphasizes that providers should not wait for laboratory confirmation before initiating treatment. The Infant Botulism Treatment & Prevention Program (IBTPP) remains available 24/7 at 510-231-7600 for immediate consultation and access to BabyBIG®. Infant botulism is a nationally notifiable condition and should be reported to state or local health departments without delay.
Parents and caregivers are advised to stop using any ByHeart Whole Nutrition infant formula, including cans and single-serve packets. Caregivers should retain leftover formula labeled “DO NOT USE” for at least a month in case testing is needed if symptoms develop. Families should closely monitor infants for signs of botulism and seek immediate medical evaluation if symptoms appear.
Health systems, laboratories, and public health partners should remove all recalled ByHeart formula from inventory, sanitize any affected feeding areas or equipment, and ensure staff are aware of reporting and testing procedures. CDC, FDA, and state health agencies continue to investigate the contamination source and will provide updates as more information becomes available.
For clinical questions, consultation requests, or BabyBIG® release, contact the IBTPP at 510-231-7600. Health departments may reach the CDC Division of Foodborne, Waterborne, and Environmental Diseases at botsurveillance@cdc.gov. After-hours public health inquiries may be directed to the CDC Emergency Operations Center at 770-488-7100.