The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are investigating a multistate infant botulism outbreak linked to Nara Organics Whole Milk Organic Powdered Infant Formula, which was sold at Target stores nationwide. Three infants in California, Washington, and Pennsylvania were hospitalized, and Nara Organics issued a voluntary recall of all its U.S. infant formula on June 13, 2026. No deaths have been reported.
Key Takeaways
- The FDA and CDC linked Nara Organics Whole Milk Organic Powdered Infant Formula to three confirmed cases of infant botulism, with illness onset between April and May 2026.
- Nara Organics recalled all lots of its U.S. infant formula on June 13, 2026, one day after the FDA notified the company of the outbreak.
- The formula was sold at Target stores, Target.com, and Nara.com between July 2025 and June 2026, and was not distributed outside the United States.
- No lots of Nara Organics formula have tested positive for Clostridium botulinum, and the FDA investigation remains ongoing.
What Prompted the Nara Organics Recall?
Nara Organics recalled all of its Whole Milk Organic Powdered Infant Formula after federal health officials connected the product to a cluster of infant botulism cases. The California Department of Public Health’s Infant Botulism Treatment and Prevention Program reported three toxin type A infections among infants who had consumed the formula, then notified the CDC. The FDA contacted Nara Organics on June 12, 2026, recommending a recall based on the severity of the illnesses and the epidemiological signal. Nara Organics agreed the following day.
The recall covers every lot of the product, sold in 700-gram (UPC 860013251901) and 400-gram (UPC 860013251918) containers. The formula was manufactured in Europe and distributed only within the United States. Nara Organics stated that it is working with the FDA, CDC, and state partners on the investigation into the root causes of the cases and described the recall as an action taken out of caution.
Where Was the Formula Sold and During What Period?
Nara Organics Whole Milk Organic Powdered Infant Formula reached consumers through Target retail stores, Target.com, and Nara.com. The affected products were available between July 2025 and June 2026. The FDA has noted that Nara Organics formula accounts for less than 1% of all infant formula sold in the United States, meaning the recall does not raise broader supply concerns for parents and caregivers.
Customers who purchased the formula directly from Nara.com between May and June 2026 are set to receive an automatic refund. Parents who still have the product at home are advised to stop using it. The CDC recommends photographing any remaining container, recording the lot number and use-by date, and retaining opened cans in case state health officials request them for testing.
How Serious Is Infant Botulism?
Infant botulism is a rare illness that occurs when a baby swallows spores of Clostridium botulinum, which can then grow and produce a toxin inside the digestive tract. All three infants in the outbreak were hospitalized and received BabyBIG, also known as Botulism Immune Globulin Intravenous, and all were treated successfully.
A complicating factor is timing. Symptoms of infant botulism can take several weeks to a month to appear after a baby consumes contaminated formula, which can make it difficult to connect an illness to its source as awareness of the recall grows. The CDC advises parents to seek immediate medical care if an infant who consumed Nara Organics formula shows signs such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression. Additional symptoms include constipation, a weak or altered cry, and low muscle tone. Clinicians treating affected infants are advised to begin treatment based on clinical presentation rather than waiting for laboratory confirmation.
What Does the Testing Show So Far?
As of the latest FDA update, no lots of Nara Organics Powdered Infant Formula have tested positive for Clostridium botulinum. Nara Organics has stated that its own batch testing, which screens for sulphite-reducing clostridia and other spore-forming organisms, has not returned a positive result for the bacterium. Officials in two states collected leftover formula from the affected households, and those laboratory results are pending.
Powdered infant formula is not a sterile product, unlike ready-to-feed formula, and spores can occasionally be present. The Nara Organics outbreak is the second powdered infant formula botulism outbreak in the United States in under a year, following a separate outbreak tied to ByHeart formula that was linked to dozens of cases across multiple states in late 2025. The pattern has drawn FDA attention to testing standards for spore-forming pathogens in infant formula.
The Nara Organics recall underscores that even trace contamination risk in infant formula can trigger a nationwide response, and federal officials continue to investigate the source.
Disclaimer: This article is intended for informational and news reporting purposes only and should not be considered medical advice, diagnosis, or treatment. Information presented is based on public statements, investigation updates, and recall notices issued by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and related agencies as of the publication date. The investigation remains ongoing, and findings or recommendations may change as additional evidence becomes available. Parents or caregivers who believe an infant may have consumed an affected product or who observe symptoms consistent with infant botulism should seek immediate medical attention and consult a qualified healthcare professional. Readers should refer to official government sources and product recall notices for the most current information.
FAQs
Which Nara Organics product is being recalled? All lots of Nara Organics Whole Milk Organic Powdered Infant Formula are recalled, in both the 700-gram and 400-gram container sizes.
Where was the recalled formula sold? The formula was sold at Target stores, Target.com, and Nara.com between July 2025 and June 2026. It was not sold outside the United States.
Have there been any deaths? No deaths have been reported. All three hospitalized infants were treated and recovered.
Has the formula tested positive for the bacteria? No lots have tested positive for Clostridium botulinum as of the latest update. Testing of leftover formula from affected households is ongoing.
What should parents do with leftover formula? Stop using it immediately, photograph the container, record the lot number and use-by date, and retain opened cans in case officials request them.
When should a parent seek medical care? Seek care right away if an infant who consumed the formula shows poor feeding, loss of head control, difficulty swallowing, or decreased facial expression.
