FDA urges recall of Nara Organics formula after infant botulism cases
FDA told parents to stop using Nara Organics infant formula after four babies in three states developed botulism and were hospitalized.
Four infants in California, Pennsylvania and Washington developed confirmed botulism and were hospitalized after using Nara Organics Whole Milk Organic Infant Formula.
Federal health officials urged parents and caregivers to stop using the recalled product, which covers all lots and both can sizes of the formula. It was sold nationwide through Target stores, Target.com and Nara.com between July 2025 and June 2026. The formula accounted for less than 1% of infant formula sold in the United States, so officials do not expect shortages. No formula had tested positive for Clostridium botulinum at the time of the recall notice.
As of July 6, the four affected infants were between 68 and 153 days old when symptoms began, with illnesses starting in April and May 2026. All four were hospitalized and treated with BabyBIG, the standard treatment for infant botulism. The CDC, the Food and Drug Administration, the Infant Botulism Treatment and Prevention Program at the California Department of Public Health and state health officials are still investigating. Leftover formula from the cases has been collected for laboratory testing, and epidemiologic data indicate the product may have been contaminated with Clostridium botulinum.
Parents and caregivers are being told to stop feeding the formula immediately and watch for warning signs that can take weeks to appear after exposure. Infant botulism often begins with constipation, then may progress to difficulty feeding, a weak or altered cry and loss of muscle tone. Any infant showing those symptoms needs prompt medical attention.
The FDA contacted Nara Organics on June 12, 2026, and recommended a recall because of the severity of the illnesses and the epidemiological signal. Nara Organics issued a voluntary recall on June 13. The formula was manufactured in Europe, and the FDA is asking families who still have opened product to photograph the container, record the lot number and use-by date, and consider keeping it for state health testing if symptoms develop.
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