FDA Calls On Infant Formula Industry to Safeguard Against Contaminants Introduced Through Supply Chains

Short summary

FDA issued a letter to infant formula manufacturers on July 13, 2026, urging increased supply chain vigilance after two multistate infant botulism outbreaks linked to Clostridium botulinum contamination in a dairy ingredient. The letter also references a global cereulide intoxication outbreak and reminds manufacturers of obligations under 21 CFR Parts 106 and 117 and the Food and Drug Omnibus Reform Act of 2022. FDA expects supplier audits, recall monitoring, and Import Alert tracking.

• •FDA letter responds to infant botulism outbreaks linked to contaminated dairy ingredient
• •Manufacturers urged to audit suppliers and monitor recalls and Import Alerts
• •Obligations under 21 CFR Parts 106/117 and FDORA 2022 reiterated

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