FDA calls on the infant formula industry to better safeguard against contaminants introduced through their supply chain.
FDA expects manufacturers to exercise substantive oversight of their suppliers and whether risks are effectively controlled.
FDA recommends infant formula manufacturers and supply chain partners monitor applicable recall notifications, outbreak investigations, and import alerts.
FDA is investigating root causes of 2025 and 2026 infant botulism outbreaks associated with powdered infant formula and has completed initial surveillance.
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