The FDA and the CDC are reporting a fourth baby has been added to the list of infant botulism victims linked to Nara Organics Whole Milk Organic Infant Formula.
The latest victim is a resident of California.
All four of the outbreak victims are male babies ranging in age from 2 to 5 months at onset of illness.
All four babies were hospitalized and treated with BabyBIG.
The California Department of Public Health has detected Clostridium botulinum in an opened can of Nara Organics powdered infant formula obtained from the home of one of the infants. FDA has collected unopened samples from the lot numbers fed to the affected infants for testing, but results are not yet available.
The Nara Organics infant formula was manufactured by the German company, Milchwerke “Mittelelbe” GmbH, and packaged by the Danish company, Advanced Nordic Nutrition.
Prior to becoming aware of the outbreak, the FDA conducted inspections at both facilities and documented several deficiencies. As a result of the inspections, the FDA added Milchwerke “Mittelelbe” GmbH to Import Alert 40-05: “Detention Without Physical Examination Of Adulterated And Misbranded Infant Formula.”
Although the infant formula was manufactured in Germany, at least some of the production batches contained whole organic milk powder supplied by Organic West Milk (a California company) and spray-dried by Dairy Farmers of America’s (Fallon, Nevada). This is the same supplier that furnished whole milk powder to ByHeart.
The FDA is continuing to work with all of the firms involved to determine the root cause of the contamination.
Organic West Milk, the supplier of whole organic milk to ByHeart and to Nara Organics, provided the FDA with an incomplete customer list during the agency’s investigation of the ByHeart botulism investigation, according to an FDA Outbreak Investigation update released on June 26, 2026.
By doing so, Organic West hid the fact that it had supplied milk to a second infant formula manufacturer. By this sin of omission, Organic West put additional infants at risk of contracting infant botulism.
The unpasteurized whole milk was shipped from Organic West Milk, a California-based company, to Dairy Farmers of America’s Fallon, Nevada facility (DFA) for pasteurization and spray-drying.
The FDA has not revealed whether or not it had also requested a customer list from DFA. Nor has it stated whether any other infant formula manufacturers were listed as customers either of Organic West or DFA.
Outbreak update
As of the June 26, 2026 update from the CDC, three babies have been stricken with infant botulism after consuming Nara Organics Whole Milk Organic Infant Formula.
The affected infants live in California, Pennsylvania, and Washington. All three were hospitalized, and have been treated with BabyBIG antitoxin supplied by the State of California. All three are expected to survive.
The infants were between 2 and 5 months of age at the time they began to develop symptoms. All three are male. The three babies became ill on April 20, May 20, and May 31, 2026.
Three different production lots of Nara Organics powdered formula were identified as having been fed to the babies: 709125280E14F2, 709125288E14F2, and 708125174E14F2.
On June 13, 2026, Nara Organics recalled “…all cans of Nara Organics infant formula currently available in the U.S.”
Outbreak investigation status
Officials in two of the three states where illnesses were reported have collected leftover infant formula to test for Clostridium botulinum. The FDA has obtained unopened samples of the three lots consumed by the affected babies and is in the process of testing those samples.
Prior to learning of the outbreak, the FDA already had conducted inspections at Milchwerke Mittelelbe GmbH and Advanced Nordic Nutrition, the two European companies involved in the manufacture and packaging of Nara Organics powdered formula.
Those inspections resulted in the identification of “deficiencies” which the companies are in the process of correcting.
Where was the contaminated formula made?
Based on US customs records, Nara Organics has received nine shipments of powdered infant formula from its European suppliers. The most recent shipment arrived on April 30, 2026. There is no record of the company having received a shipment from any other off-shore supplier.
NOTE: This post has been amended to reflect corrected information on the overseas shipments received by Nara Organics. eFoodAlert apologies for any confusion.
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“Reads like a true crime novel” – Food Safety News
Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?
Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.
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