Nara Organics posted an update on August 27, 2026, the same day the Food and Drug Administration and the Centers for Disease Control and Prevention declared the infant botulism outbreak linked to its Whole Milk Organic Infant Formula over, saying it plans to bring the formula back to U.S. shelves with European dairy and what it calls rigorous Clostridium botulinum testing. Four infants in California, Pennsylvania and Washington were hospitalized with botulism after drinking the formula in April and May 2026. All four survived. The formula was recalled June 13, 2026.
FDA and CDC say the formula was contaminated and made the babies sick.
This is not a case of a company recalling out of caution. CDC’s closing statement says epidemiologic, traceback and laboratory data showed that Nara Organics Whole Milk Organic Infant Formula was contaminated and made infants sick, and that the data indicate a common source of contamination for this outbreak and the 2025 outbreak linked to ByHeart Whole Nutrition Infant Formula. FDA’s page goes further: whole genome sequencing matched a Nara patient’s bacteria to a ByHeart patient, to a ByHeart base powder sample, and to four sealed, unopened cans of ByHeart formula. The ByHeart outbreak hospitalized 48 infants in seventeen states. Between the two brands, 52 babies were hospitalized with a disease that paralyzes.
Both formulas were made with milk from Organic West Milk that was spray dried by Dairy Farmers of America. That is the common source both agencies point to. What neither agency can say is whether the milk was contaminated before it reached the dryer or during drying. Nara’s update says its outbreak may be linked to one of its former dairy suppliers, the same suppliers as ByHeart’s. That is a careful way of describing a finding the government stated plainly. I went through the update line by line on Marler Blog and set what Nara wrote next to what FDA wrote.
Negative toxin tests on sealed cans do not tell you the powder is free of spores.
Nara says every test on sealed cans of its formula came back negative for C. botulinum toxin type A and type B. Parents should understand what that does and does not mean. Powdered formula does not carry botulism toxin. It carries spores, which are dormant, scattered unevenly through the powder, and harmless to older children and adults. Infant botulism happens when a baby swallows spores, the spores germinate in a gut whose bacteria are not yet developed enough to stop them, and the toxin is made inside the baby. A can may test negative for toxin and still contain the spores that put a child in the hospital. In the ByHeart outbreak FDA found the organism itself in the product and in the milk powder that went into it. A relaunch built on toxin testing is testing for the wrong thing.
The signs of infant botulism come on slowly and can take weeks.
The first sign is usually constipation, followed by poor feeding, a weak cry that sounds different from normal, drooping eyelids, a face that shows less expression than usual, pupils slow to react to light, and a loss of head control that parents describe as the baby going floppy. CDC warns that symptoms can take as long as several weeks to develop after a baby eats contaminated formula. Any infant who ate the recalled Nara formula, or any formula, and shows these signs needs to be seen immediately. Infant botulism is treatable with an antitoxin called BabyBIG, and the earlier it is given the shorter the hospital stay.
What to do now.
If you still have Nara Organics Whole Milk Organic Infant Formula from before the recall, do not use it; CDC says to throw away unopened cans and leftover product. If a relaunched Nara product reaches shelves, the questions worth asking before buying are simple ones: where the milk came from, who dried it, and whether the company tests the powder for the organism rather than the toxin. Nara says its newest batches use European dairy and were not part of the recall. The update does not say how that testing is done. Families of two of the four Nara infants have filed suit, and the earlier coverage of this outbreak on this blog is here, with the ByHeart outbreak here.
Three questions parents are asking.
Is Nara formula safe now? The recalled formula is not. FDA and CDC concluded it was contaminated and made four infants sick. Nara says future batches will use European dairy and toxin testing; the update does not say whether FDA has reviewed the change, and the root cause of the contamination in both the Nara and ByHeart outbreaks has not been found.
What are the first symptoms of infant botulism? Constipation, poor feeding, a weak or changed cry, drooping eyelids and loss of head control. Symptoms can appear weeks after the formula was eaten. Seek care immediately.
Was Nara formula linked to the ByHeart outbreak? Yes. FDA matched a Nara patient’s Clostridium botulinum by whole genome sequencing to a ByHeart patient and to unopened ByHeart cans, and both agencies say the two outbreaks share a common source: milk from the same supplier, dried by the same facility.