- On July 13, 2026, FDA issued a letter to infant formula manufacturers and their supply chain partners in response to several serious public health events, calling on the industry to increase vigilance to “ensure ingredient and infant formula safety.”
- The letter details FDA’s investigation into two multistate outbreaks of infant botulism that led to voluntary recalls of powdered infant formula, as we previously reported. The investigation identified Clostridium botulinum contamination in a dairy-based ingredient, which FDA linked to both affected formulas. In addition, the letter discusses a global outbreak of cereulide intoxication, which resulted in an ingredient supplier being placed on an FDA Import Alert.
- In the letter, FDA emphasizes that these incidents reflect a pattern of risks entering through the supply chain. The letter outlines FDA’s expectation for manufacturers to conduct supplier audits and verification activities, as well as monitor recalls, outbreak investigations, and FDA Import Alerts. The letter also reminds the industry of its obligations under 21 CFR Parts 106 and 117 and the Food and Drug Omnibus Reform Act of 2022.
- The letter concludes by stating that FDA is continuing its investigations into the root causes of the 2025 and 2026 infant botulism outbreaks and provides industry with a list of resources, including Information for Infant Formula Manufacturers and Retailers and Guidance for Industry: Hazard Analysis and Risk-Based Preventative Controls for Human Food.
- Keller and Heckman will continue to report on developments related to infant formula manufacturing.
