US — The U.S. Food and Drug Administration (FDA) reported deficiencies at Nara Organics' facilities on June 26, 2026, following the company's voluntary infant formula recall earlier that month. A June 2026 advisory from the California Department of Public Health linked three infant botulism cases from late April and May to Nara Organics' formula. A lawsuit was filed against Nara Organics in late June 2026, alleging that a baby contracted botulism from its infant formula. Nara Organics formula is manufactured in Germany.

Multiple brands of infant formula have been recalled in the last year due to bacterial contamination, with two recalls specifically linked to active bacterial outbreaks. Food Safety Magazine found that Nara Organics used whole milk powder from Organic West, a supplier that also provided powder to ByHeart. ByHeart recalled its formula in November 2025 following an infant botulism outbreak connected to 48 hospitalizations across 17 states. The whole milk powder found in both contaminated formulas was manufactured in Nevada, while ByHeart formula is manufactured in Iowa. The FDA report stated there is insufficient evidence to conclude whole milk powder was the source of contamination.

The FDA launched Operation Stork Speed in March 2025 to "expand options for safe, reliable, and nutritious infant formula for American families." Tom Brenna, a professor at the Dell School of Medicine with expertise in pediatrics and food science, was brought onto Operation Stork Speed to help design regulations for nutrition. "I regret to say there has not been any movement [on Operation Stork Speed] since the summer of 2025, at least none that I know of," Brenna said in an email. An FDA spokesperson stated that Operation Stork Speed is "continuing as planned."

Sarah Mayne, a professor of public health at Yale and former director of the FDA's Center for Food Safety and Applied Nutrition, said the FDA's workforce for inspecting facilities and preventing contamination has been reduced and is "especially lacking infant formula investigators." Mayne served as director of the FDA's Center for Food Safety and Applied Nutrition across three presidential administrations. She said, "When it came to resources and personnel at the FDA, I frequently said we can always do more with more. Well, now, the FDA is of course doing less with less." An FDA spokesperson claimed the administration more than doubled its infant formula staffing. The FDA spokesperson also stated the agency requested that Congress mandate more accountability from the industry, including requiring companies to report any positive pathogen testing results. The FDA reportedly conducts 21 recall checks within the first week of the ByHeart response, compared to nearly 2,000 conducted by states during the same period. The FDA requires all infant formula manufacturers to be inspected annually, but these rules do not apply to ingredient suppliers. An FDA spokesperson said the agency was continuing to investigate the root causes of contamination through supply chain assessment and surveillance sampling.