A multistate outbreak of infant botulism linked to Nara Organics Whole Milk Organic Powdered Infant Formula has sickened three infants in California, Pennsylvania, and Washington, with onset between April and May 2026. All three were hospitalized; no deaths have been reported. The FDA recommended a recall on June 13, 2026, and Nara Organics agreed. The product was sold at Target stores, Target.com, and Nara.com from July 2025 to June 2026. This is the second formula-linked botulism outbreak in the U.S. in less than a year, following the ByHeart outbreak in November 2025 that affected 48 infants across 17 states. For overseas buyers and distributors of infant formula ingredients, including whole milk powder, this signals heightened regulatory scrutiny and potential shifts in sourcing requirements for organic dairy components.
Outbreak details and regulatory response
The FDA, CDC, California Department of Public Health, and the Infant Botulism Treatment and Prevention Program are investigating. The implicated product is Nara Organics Whole Milk Organic Powdered Infant Formula, manufactured in Europe. The FDA recommended the recall due to the severity of illnesses and epidemiological signal. Whole-genome sequencing in the earlier ByHeart outbreak tied Clostridium botulinum to organic whole milk powder, a pattern repeated here. No deaths have been reported, but all three infants required hospitalization.
Industry accountability and supply-chain implications
Food safety attorney Bill Marler, who represents families from the ByHeart outbreak, stated: "For the second time in seven months, parents are being told that the powdered formula they trusted to feed their baby may carry the toxin that causes botulism — and once again, the implicated ingredient is whole milk powder, and once again the product was on the shelves at Target." Marler criticized the FDA and industry for not implementing pre-shipment testing for botulism, noting that the FDA had warned manufacturers about Clostridium botulinum in powdered infant formula in March 2023. He added: "A recall after the fact is not a food safety system — it is a bad apology."
What buyers should watch
Importers and distributors of organic whole milk powder for infant formula should monitor FDA and CDC updates closely. The repeated link to organic whole milk powder suggests potential supply-chain vulnerabilities in sourcing and testing protocols. Buyers may need to verify that suppliers implement routine testing for Clostridium botulinum spores before shipment, rather than relying on post-market surveillance. The FDA's warning letters to retailers after the ByHeart outbreak — including Target, Walmart, Kroger, and Albertsons — for failing to remove recalled formula from shelves indicate that enforcement gaps persist.
Sourcing context
The Nara Organics formula was manufactured in Europe, highlighting that contamination risks are not limited to any single region. For overseas buyers, this outbreak underscores the importance of auditing suppliers for botulism control measures, particularly for organic whole milk powder. The FDA's 2023 written guidance naming Clostridium botulinum as a known hazard in powdered infant formula means that regulatory expectations are already on record. Distributors should expect increased scrutiny from U.S. import authorities and potentially from other markets adopting similar standards.
Source: Read the original report | Published: June 13, 2026