Courtesy FDA
Three infants in three states have developed confirmed or suspected botulism illnesses after consuming Nara Organics powdered infant formula, prompting a nationwide recall and federal investigation.
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP) and state and local partners, are investigating the outbreak, with cases reported in California, Pennsylvania and Washington.
The CDPH IBTPP reported three toxin type A infections among infants consuming Nara Organics Whole Milk Organic Powdered Infant Formula, with illness onset between April and May 2026. All three consumed Nara Organics-brand powdered infant formula.
Officials in two states have collected leftover infant formula for testing. FDA said results are expected in the coming weeks.
On June 12, FDA contacted Nara Organics, based in New York, N.Y., to notify them of the outbreak and recommended a recall. On June 13, Nara Organics agreed to recall all lots of its whole milk organic powdered infant formula.
The recalled powdered infant formula was distributed nationally across Target retail stores, Target.com and Nara.com between July 2025 and June 2026. All of Nara Organics' formula was manufactured in Europe, but the formula is not distributed outside of the United States, reported FDA.
The investigation comes less than a year after federal health officials investigated another infant botulism outbreak linked to ByHeart powdered infant formula, which sickened and hospitalized 48 infants.
FDA’s investigation of the Nara Organics outbreak is ongoing. This advisory will be updated as information becomes available.
For more information about FDA’s efforts to ensure the safety of infant formula, visit the agency’s Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula webpage.
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