Potential Cause of ByHeart Infant Botulism Outbreak May Be Whole Milk Ingredient

The outbreak has infected 51 babies across the United States, with all of them getting hospitalized.

A container of ByHeart baby formula, which was recently recalled by ByHeart, in Flagstaff, Ariz., on Wednesday, Nov. 12, 2025. AP Photo/Cheyanne Mumphrey

A multistate outbreak of botulism linked to infant formula products sold by New York-based ByHeart could have originated from whole milk powder used in the product, according to a Jan. 23 statement from the Centers for Disease Control and Prevention.

On Nov. 11, ByHeart announced the recall of all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack due to contamination from Clostridium botulinum, a bacterium that can cause life-threatening illness or death.