On November 8, 2025, health officials announced an investigation into a multistate outbreak of infant botulism linked to specific lots of ByHeart Whole Nutrition Infant Formula. The Centers for Disease Control and Prevention (CDC), along with the FDA and other public health authorities, are actively responding to this critical situation.
Details of the Outbreak
The investigation currently indicates 13 confirmed cases across 10 states. All affected infants have been hospitalized, but fortunately, no fatalities have been reported. Symptoms of infant botulism often begin with constipation and include poor feeding, difficulty in swallowing, and a weak cry.
Recalled Products
- Manufacturer: ByHeart Inc.
- Recalled Lots:
- Lot 206VABP/251261P2 (“Use by 01 Dec 2026”)
- Lot 206VABP/251131P2 (“Use by 01 Dec 2026”)
- Distribution: Available online and at major retailers nationwide.
These two lots of infant formula represent approximately 1% of all infant formula sales in the U.S. The FDA has indicated that this situation does not create shortage concerns for parents and caregivers seeking infant formula.
Guidance for Parents and Caregivers
- Do not use the recalled infant formula. Dispose of it or return it to the store.
- Record the lot number when returning the product.
- Clean any items or surfaces that may have come into contact with the recalled formula using hot, soapy water.
- If your infant exhibits symptoms such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate medical attention.
It is important to note that symptoms of infant botulism can take several weeks to manifest, which necessitates vigilance for those who have used the affected lots of formula.
Recommendations for Manufacturers and Clinicians
What Businesses Should Do
- Immediately cease sales and use of the recalled products.
- Ensure thorough cleaning and sanitization of any equipment or surfaces that may have been contaminated.
Clinical Response
The initial diagnosis of infant botulism is made based on clinical symptoms. Clinicians suspecting cases of this serious condition are urged to contact the Infant Botulism Treatment and Prevention Program at 510-231-7600 on a 24/7 basis for guidance.
In cases where infant botulism is suspected, treatment should commence without delay, even before laboratory confirmation. This condition is classified as a notifiable disease, requiring all suspected instances to be reported to relevant public health authorities.
Infant botulism can lead to severe complications, including flaccid paralysis and respiratory failure, necessitating prolonged medical care. Treatment with BabyBIG® is advised for all suspected cases.
