Infant Formula Recalled in Wake of Botulism Outbreak

November 13, 2025

The Centers for Disease Control and Prevention (CDC) and public health officials in several states, including at the Minnesota Department of Health (MDH), are investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. 

As of November 8, 13 infants with suspected or confirmed infant botulism have been reported in 10 states. One case was reported in Minnesota in August. No deaths have been reported. Infants ranged in age from 16 days to approximately 6 months. 

On November 8, ByHeart Inc. recalled two lots of Whole Nutrition Infant Formula: 

• Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”) 

• Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”) 

ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide. Additional lots may be recalled as the investigation continues. Parents should not use recalled infant formula and throw it away or return it to where it was purchased. If an infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms, parents should reach out to their health care provider immediately: 

• Poor feeding 

• Loss of head control 

• Difficulty swallowing 

• Decreased facial expression 

ByHeart Whole Nutrition Infant Formula makes up less than 1% of all infant formula sales in the United States, and this outbreak does not create shortage concerns of infant formula for parents and caregivers. 

Additional information about this outbreak can be found on the CDC’s website: Infant Botulism Outbreak Linked to Infant Formula, November 2025. 

Additional information about botulism can be found on the MDH website: Botulism (Clostridium botulinum toxin).