Federal Agencies Investigate Infant Botulism Outbreak Linked to Powdered Formula

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), in conjunction with state and local health partners, are actively investigating a multistate outbreak of infant botulism illnesses. The investigation, which began in June 2026, has identified four infants in California, Pennsylvania, and Washington who have been diagnosed with infant botulism. All affected infants reportedly consumed Nara Organics Whole Milk Organic Powdered Infant Formula. The FDA has issued a strong advisory urging consumers to immediately stop using this specific product.

The investigation has revealed that the Nara Organics Whole Milk Organic Powdered Infant Formula was distributed nationwide through Target retail stores, Target.com, and Nara.com, with distribution occurring between July 2025 and June 2026. While the FDA is in the early stages of its investigation and further testing is ongoing, initial findings from the California Department of Public Health have detected Clostridium botulinum in an opened can of the formula obtained from the home of one of the sick infants. The FDA is conducting its own analysis of unopened samples from the same lot numbers.

Infant botulism can be a serious and potentially fatal condition. Symptoms, which can take several weeks to develop after ingestion of contaminated formula, typically begin with constipation, poor feeding, loss of head control, and difficulty swallowing. These symptoms can progress to more severe issues, including breathing difficulties and respiratory arrest. The FDA is advising parents and caregivers to seek immediate medical attention if their child exhibits any of these signs and symptoms after consuming Nara Organics Whole Milk Organic Powdered Infant Formula.

Parents and caregivers who have the Nara Organics formula in their possession are instructed to take a photograph of the container and record the lot number and use-by date. It is recommended to label the product “DO NOT USE” and store it safely away from other feeding items for at least one month. If no symptoms appear in the infant after this period, the remaining formula should be discarded. All items and surfaces that may have come into contact with the formula should be thoroughly washed with hot, soapy water or cleaned in a dishwasher. Physicians who suspect a patient may have botulism are advised to contact the Infant Botulism Treatment and Prevention Program immediately for consultation.

The Nara Organics Whole Milk Organic Powdered Infant Formula represents less than one percent of the total infant formula market in the United States, and federal health officials have indicated that this outbreak is not expected to cause shortages of infant formula for parents and caregivers. The FDA is continuing its collaborative efforts with the manufacturing firms involved to identify the root cause of the contamination and to determine if any other products may be affected. This advisory will be updated as new information becomes available.

Article by Mel Anara, based upon information from the U.S. Food and Drug Administration.

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