Infant Botulism Outbreak Linked to Infant Formula, November 2025
CDC and FDA are concerned that other lots of ByHeart Whole Nutrition infant formula may be contaminated and are making infants sick with infant botulism. Parents and caregivers have reported feeding infants in this outbreak different lots of ByHeart infant formula that were not included in the company’s recall on November 8, 2025. On November 11, 2025, ByHeart Inc. recalled all ByHeart Whole Nutrition infant formula products.
Parents and caregivers are urged to stop using any ByHeart Whole Nutrition infant formula immediately. This includes:
- All lot numbers
- All sizes of cans and single serve packets
ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
Please click here for more details located on the CDC website.
