WASHINGTON, DC — Federal health officials say a multistate infant botulism outbreak linked to Nara Organics Whole Milk Organic Powdered Infant Formula has ended, but the investigation points to a contamination issue that may extend beyond a single recall. The Food and Drug Administration said four confirmed cases were identified in infants in California, Pennsylvania and Washington, with all four children hospitalized and no deaths reported.
The outbreak involved formula sold nationally through Target stores, Target.com and Nara.com between July 2025 and June 2026. The FDA said recalled products should no longer be on sale, but families should still check their homes for cans with “Best By” dates ending in 2027 and throw away any remaining formula. The agency also warned parents to wash bottles, counters and other items that may have come into contact with the product.
How investigators linked the Nara formula to the illnesses
FDA and state partners worked with the California Department of Public Health, the Infant Botulism Treatment and Prevention Program and local health agencies to examine samples from sick infants and from unopened cans of formula. By August 27, 2026, the Centers for Disease Control and Prevention had declared the outbreak over, and the FDA said no new cases had been added since July 3.
The agency said whole genome sequencing, or DNA fingerprinting, showed that one clinical sample from an infant in this outbreak matched a sample from an infant in the 2025 ByHeart outbreak. That same genetic pattern also matched a powdered infant formula base sample from the earlier investigation and four unopened cans of ByHeart formula. FDA said those findings, combined with supply chain overlaps, indicate a common source of contamination between the two outbreaks.
Officials have not determined whether milk was contaminated before drying or during the drying process. FDA said its root-cause investigation is still ongoing, along with post-incident response work focused on ingredients, surveillance, prevention and compliance.
The recalled product was shipped nationwide through major retailers and online
The recalled product was Nara Organics Whole Milk Organic Powdered Infant Formula, which FDA said was distributed nationwide through Target retail stores, Target.com and Nara.com. The company’s infant formula was not distributed outside the United States, according to the agency.
FDA said consumers should not use the recalled formula and should discard any cans still in the home. The product being investigated carried “Best By” dates ending in 2027, which means some affected cans may still be in pantries, diaper bags or storage areas even after the recall.
The agency also urged families to clean any bottles, formula dispensers, countertops and other surfaces that may have touched the powder using hot soapy water or a dishwasher. Those steps are meant to reduce the chance of leftover contamination in feeding equipment.
Symptoms parents and doctors were told to watch for
FDA said infant botulism can be dangerous and may take weeks to appear after an infant drinks contaminated formula. Early symptoms can include constipation, poor feeding, loss of head control and difficulty swallowing. Those signs can later progress to difficulty breathing and respiratory arrest if treatment is delayed.
The illness is diagnosed clinically, and federal health officials stressed that rapid medical attention matters. Parents who notice signs of botulism in an infant were told to seek immediate care.
For physicians who suspect botulism in an infant patient, FDA said the Infant Botulism Treatment and Prevention Program should be called right away at 510-231-7600. The consultation line is available 24 hours a day, seven days a week.
What the case count showed by the end of the investigation
As the investigation wrapped up, FDA said the outbreak included four confirmed infant botulism cases. All four infants were hospitalized, and no deaths were reported. The last illness onset was May 31, 2026, according to the agency’s case summary.
The illnesses were spread across three states: California, Pennsylvania and Washington. FDA and CDC had initially described the event as three cases, then updated the total as additional information came in. By late August, no new cases had been added for weeks, allowing CDC to close the outbreak.
Public health officials said the investigation included samples from patients, unopened product and ingredients. The case map and summary were intended to show where the illnesses occurred and help state and federal partners identify whether more product or more people were affected.
Why investigators say the contamination issue may involve the milk supply
FDA said the Nara Organics formula lots tied to illness were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America. Those are the same suppliers involved in the 2025 ByHeart powdered infant formula investigation, which is why the agency believes the two outbreaks may share a common contamination source.
During the earlier outbreak, FDA said it had done a traceforward review to see whether Organic West Milk supplied other powdered formula makers. At that time, the company gave an incomplete customer list that did not show Nara Organics as a customer. In the current investigation, Organic West Milk told FDA that the earlier customer information had been incomplete and should have included suppliers to Nara Organics.
FDA said it has continued working with the companies involved in both outbreaks and with the wider infant formula industry. It is also coordinating with relevant European authorities because Nara Organics formula was manufactured in Europe.
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