The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have launched a nationwide investigation after a rare outbreak of infant botulism was linked to ByHeart Whole Nutrition Infant Formula. Thirteen babies across ten US states have been hospitalised, prompting the company to issue an immediate voluntary recall of two batches of its powdered baby formula.
Health authorities confirmed that the investigation began after a series of hospital admissions between August and November 2025 showed identical symptoms of botulism, a potentially fatal bacterial illness. While no deaths have been reported, the FDA has described the recall as a critical precautionary measure as laboratory testing continues.
