The US Food and Drug Administration (FDA) has urged the infant formula industry and supply-chain partners to exercise greater oversight of suppliers following multiple product recalls and recent infant botulism outbreaks, marking the first US outbreaks linked to infant formula in nearly 50 years. In a letter addressed to manufacturers, packagers, distributors, exporters, importers, and retailers of infant formula, the FDA said it has investigated two multistate infant botulism outbreaks associated with two powdered infant formula brands—ByHeart and Nara Organics—both of which resulted in product recalls.
The agency stated that manufacturers are expected to understand where their ingredients originate, how they are produced, the risks they may carry, and whether those risks are being effectively controlled. According to the FDA, the 2025 ByHeart outbreak was the first confirmed infant…
