On July 13, 2026, the U.S. Food and Drug Administration announced on their website that the Agency sent a letter to the infant formula industry and their supply chain partners highlighting multiple recent public health events where risks were introduced through the supply chain and to call for increased vigilance by industry to ensure the safety of ingredients and finished infant formula products.
FDA has investigated two multistate outbreaks of infant botulism associated with two separate brands of powdered infant formula — ByHeart, Inc., and Nara Organics, Inc. — resulting in voluntary recalls and an ongoing FDA investigation into the shared ingredient suppliers. Likewise, a global contamination event occurring in late 2025 through early 2026 resulted in nearly 150 suspected and confirmed cases of cereulide intoxication across 10 countries, traced to contaminated arachidonic acid (ARA) oil used as an ingredient in infant formula. This prompted multiple global downstream recalls, and a supplier of ARA oil being added to multiple import alerts.
Manufacturer Responsibility: Know Your Suppliers
The FDA expects manufacturers to exercise substantive oversight of their suppliers, including understanding where their ingredients come from, how they are produced, what risks they may carry, and whether those risks are effectively controlled. When a contaminated ingredient or supplier concern is identified, whether by FDA or through industry’s own monitoring, manufacturers are expected to act swiftly to assess and address the risk.
The FDA also recommends that infant formula manufacturers and their supply chain partners stay abreast of applicable recall notifications, outbreak investigations and import alerts, which may serve as important safety signals. Experience has shown that ignoring or downplaying these safety signals can lead to increased risks to infants and preventable public health events.
FDA Actions
The FDA acknowledges the challenges in managing the risks related to spore-forming microbes in infant formula ingredents and recognizes there might not be a single approach for addressing them. The Agency is prepared to work with industry to identify best practices and will continue to solicit advice from experts in academia and international scientific bodies, such as the Codex Committee on Food Hygiene and the International Commission on Microbiological Specifications for Foods.
The FDA also is continuing to investigate the root causes of the 2025 and 2026 infant botulism outbreaks associated with powdered infant formula and has completed initial surveillance to better understand the prevalence of Clostridium botulinum in powdered milk, the results of which are available on FDA’s Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula webpage.
