ByHeart Whole Nutrition

FDA recall and outbreak record for the brand's formula over five years: Poor. FDA's outbreak page says 48 infants (28 confirmed, 20 probable) in 17 states had infant botulism linked to ByHeart Whole Nutrition formula, all 48 were hospitalised and none died, and that all ByHeart formula, cans and single-serve packs, was recalled. It says testing found Clostridium botulinum in a base mix and in organic whole milk powder used to make the formula, and that CDC declared the outbreak over as of 26 February 2026. ByHeart also recalled five batches on 11 December 2022 for possible Cronobacter cross-contamination, and both recalls are Class I in FDA's enforcement reports (linked). Scored in the lowest tier described in the attribution. source↗ 2026-09