11/11/2025
CDC and FDA Investigate Infant Botulism Outbreak Linked to Recalled Infant Formula
LINCOLN, NE – The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are currently investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula, sold in-store and online from July 2025 to November 2025. Retailers with stores in Nebraska selling ByHeart Whole Nutrition Infant Formula include Walmart, Target, and Whole Foods Market.
The Nebraska Department of Health and Human Services (DHHS) is closely monitoring updates in the investigation and working with local health departments, the Nebraska Department of Agriculture, and retailers to ensure the recalled formula is removed from store shelves.
No cases related to this outbreak have been reported in Nebraska at this time. Related to this outbreak, the CDC has reported 13 infant botulism cases across 10 states involving infants reported to have consumed ByHeart powdered infant formula. Currently, no deaths have been reported by the CDC.
On November 8, 2025, ByHeart Inc. announced a voluntary recall of ByHeart Whole Nutrition Infant Formula from two lots:
Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")
Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")
The CDC advises parents and caregivers who purchased ByHeart Whole Nutrition Infant Formula to check the lot number and expiration date printed on the bottom of the infant formula container. Stop using it immediately if the formula is from one of the recalled lots with a “01 Dec 2026” expiration date. Either throw it away immediately or return it to the location where it was purchased. Wash all items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.
The CDC and DHHS recommend caregivers seek immediate medical care if an infant has any of the following symptoms, regardless of exposure to this product:
• difficulty sucking or swallowing during feedings,
• poor feedings,
• loss of head control,
• decreased facial expression,
• a weak or altered cry, or
• loss of muscle tone.
Symptoms of infant botulism may take several weeks to develop following exposure. Infant botulism occurs when spores of the bacteria Clostridium botulinum infect a baby’s intestine and begin to produce botulinum toxin. Infants who consumed the recalled formula need vigilant monitoring from their parent or caregiver. If untreated, infants with infant botulism may experience progressive paralysis leading to breathing difficulties, hospitalization, or death.
The CDC guidance for clinicians suspecting a patient with infant botulism is to call 510-231-7600 immediately for case consultation. Case consultation is available 24/7. Treatment with BabyBIG® (botulism immune globulin) must be administered as soon as possible following symptom onset. Do not wait for laboratory confirmation. Additional response guidance can be found by contacting the Nebraska DHHS Division of Public Health 24/7 hotline at 402-471-2937.
In addition, the CDC advises businesses not to sell or use recalled infant formula. As a safety precaution, wash and sanitize items and surfaces that may have contacted the recalled formula.
For additional information, please visit the FDA’s information website at https://bit.ly/3LBYeWg or the CDC Botulism website.