On June 13, 2026, the FDA and CDC, in collaboration with the California Department of Public Health (CDPH), announced an investigation into a multistate outbreak of infant botulism illnesses traced to Nara Organics Whole Milk Organic Powder Infant Formula. Three cases were reported in California, Pennsylvania, and Washington, with symptoms occurring between April and May 2026. All affected infants had consumed the powdered formula.
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Following the identification of these cases, the CDPH's Infant Botulism Treatment and Prevention Program reported three toxin type A infections linked to the formula. State officials have gathered leftover products for testing, with results anticipated soon.
On June 12, 2026, the FDA advised Nara Organics to issue a recall due to the serious nature of the illnesses. The company consented to recall all lots of its Whole Milk Organic Powdered Infant Formula on June 13, 2026. All formula manufactured by Nara Organics was produced in Europe. Consumers are urged not to use the recalled products and to either dispose of them or return them for a refund. Parents whose infants have ingested this formula and are showing symptoms should contact their healthcare provider immediately.
To report any illness or adverse effects, individuals can file a complaint with the FDA through various methods, including an online submission or by calling for a reporting form.
Infant formula serves as a vital nutritional source for many babies in the U.S., and ensuring its safety is a priority for the FDA. While breastfeeding is recommended, numerous infants depend on formula for all or part of their nutrition.
The FDA oversees the production of infant formulas to ensure safety and nutritional quality. Manufacturers must notify the FDA before marketing a new formula and demonstrate that their products meet nutritional and safety standards. The FDA mandates specific nutrient inclusion and requires sanitary controls during the manufacturing process to prevent contamination.
Annual inspections of formula production facilities are conducted by the FDA to ensure compliance with safety regulations, and strict labeling guidelines are enforced to provide clear usage directions and safety information.
Importantly, all infant formulas sold in the U.S. must adhere to federal safety and nutritional standards, including those imported. Caregivers are advised to exercise caution when ordering imported formulas online, as they may not comply with U.S. requirements.