ByHeart is not ruling out the possibility that all of its infant formula was contaminated less than two weeks after its products were recalled. The company initially recalled two batches of its Whole Nutrition Infant Formula on November 8th after the FDA notified it of a link between the product and a multi-state outbreak of infant botulism. According to ByHeart, after being informed of the outbreak, it tested 36 product samples and five were positive for infant botulism which led the company to say it “cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.” ByHeart said it will “continue to be focused on finding the root cause, through a rigorous audit” and has given the FDA “complete and unrestricted access” to all of its facilities, including its plant in Berks County, Pa.
Thursday 2nd April 2026
