Operation Stork Speed, which was established last year by the Department of Health and Human Services and the FDA, addresses more hazards in infant formula, more specifically, botulism and Bacillus cereus. This program builds on the 2022 strategy to increase the resiliency of the U.S. infant formula market.
The purpose of the program is to expand options for safe, reliable, and nutritious infant formula for American families. It will conduct the first review of all infant formula nutrients since 1998, and will increase testing of some contaminants in formula and other foods that children eat.
They will also add testing of ingredients for spore-forming contaminants, such as Clostridium botulinum and Bacillus cereus. There have been two infant botulism outbreaks in the past year and a half.
A botulism outbreak is associated with Nara Organics powdered infant formula. There are four infants sickened in three states. The case count is California (2), Pennsylvania (1), and Washington (1). Illness onset dates range from April through May 2026. The California Department of Public Health tested opened cans of formula taken from a home with a sick infant, and found Clostridium botulinum bacteria.
Last year, a botulism outbreak was linked to recalled ByHeart powdered infant formula. The final case count by state was: Arizona (5), California (12), Idaho (2), Illinois (2), Kentucky (1), Massachusetts (2), Michigan (1), Minnesota (3), North Carolina (2), New Jersey (1), Oregon (3), Pennsylvania (1), Rhode Island (1), Texas (8), Virginia (1), Washington (2), and Wisconsin (1). The infants ranged in age from 16 to 264 days. Illness onset dates ranged from December 24, 2023 to November 29, 2025.
The plan also will encourage companies to work with the FDA on questions about transparency and clearer labeling. They will also be encouraged to communicate regularly with consumers about developments about nutrients, health outcomes, and safety findings.
While there have not been any Bacillus cereus infant formula outbreaks, one product was recalled in May 2026 for a toxin the pathogen produces. Three batches of a2 Platinum was recalled when officials found cereulide, the heat stable toxin produced by some Bacillus cereus strains, was found in the formula. No illnesses were reported at the time of the recall.
