The FDA linked the product to type A botulinum toxin in three infants across California, Pennsylvania, and Washington, and food safety lawyers are calling it the second formula linked outbreak in seven months.
Nara Organics is pulling every lot of its Whole Milk Organic Powdered Infant Formula after the FDA linked the product to three hospitalized infants in California, Pennsylvania, and Washington with type A botulinum toxin. The recall covers formula distributed from July 2025 through June 2026 and sold at Target stores, Target.com, and Nara.com, according to the FDA's outbreak investigation notice updated June 13, 2026.
For parents who already have a can in the pantry, the next few hours matter. Stop using the product. Do not throw it away. Mark the container "DO NOT USE," photograph the label and lot number, and store it away from other food so it can be tested if investigators ask. Then watch the child. The early symptoms of infant botulism are easy to miss: constipation, poor feeding, a weak cry, loss of head control, and a floppy or "rag doll" feel. Any of those calls for a clinician the same night, not a wait-and-see morning.
The three confirmed cases were identified by the FDA, the CDC, the California Department of Public Health, and the Infant Botulism Treatment and Prevention Program, with illness onsets between April and May 2026, the FDA notice states. All three infants were hospitalized; no deaths have been reported. The recall covers all lots distributed in the July 2025 to June 2026 window, and the FDA recommended the action because of the severity of botulism illness in infants. The product was manufactured in Europe. No Nara formula has yet tested positive for Clostridium botulinum, and testing of leftover product collected from two states is underway, according to the FDA.
The outbreak is the second formula-linked infant botulism event in the United States in less than a year. The prior event, involving ByHeart Whole Nutrition Infant Formula, sickened 48 infants across 17 states between October and November 2025, put all 48 in the hospital, and was traced to Clostridium botulinum in an organic whole milk powder ingredient. That outbreak is now the subject of an ongoing FDA root-cause investigation focused on ingredients. Nara Organics' implicated product is also a whole-milk powdered formula, also manufactured in Europe, also distributed through a major national retailer.
Food safety attorney Bill Marler, whose firm represents more than 20 families from the ByHeart outbreak, called the Nara Organics event the second formula-linked infant botulism outbreak in seven months and renewed his demand that the FDA and the infant formula industry do more. "A recall after the fact is not a food safety system — it is a bad apology," Marler said in a statement included in a Marler Clark press release distributed via PR Newswire on June 13. Marler's characterization of the repeat-outbreak pattern is a sourced observation from an advocacy posture; the underlying pattern — two powdered whole-milk infant formula outbreaks in under a year, both linked to European-manufactured product and both resulting in mass hospitalizations — is consistent with the confirmed public record from FDA and CDC.
Nara Organics issued a voluntary recall on June 13, 2026, after receiving epidemiological information from the FDA on June 12. The company states on its recall page that it "extensively tests every batch of formula beyond FDA and European Union requirements" and that no Nara formula has yet tested positive for C. botulinum. Refunds are being processed automatically for customers who purchased from Nara.com in May or June 2026; Target customers may return product at any Target store.
What to watch next: the results of ongoing product testing from two state health departments, the FDA's root cause investigation — which will likely examine the supply chain for European whole milk powder as a shared ingredient risk — and any CDC update to case definitions or exposure history. Parents and clinicians should continue to monitor the FDA outbreak investigation page and the CDC outbreak page for updated case counts and clinical guidance.