The latest update comes as investigators examine whether contamination occurred within the product supply chain. According to the U.S. Food and Drug Administration (FDA), the investigation remains active, and officials have not yet determined the root cause of the outbreak.
The FDA and the Centers for Disease Control and Prevention (CDC), working alongside state health agencies, are investigating four confirmed infant botulism illnesses reported in California, Pennsylvania, and Washington. According to the FDA, all four infants consumed Nara Organics Whole Milk Organic Powdered Infant Formula before becoming ill between April and May 2026.
Investigation Expands as Fourth Case Is Confirmed
The FDA announced on July 6 that the outbreak now includes four confirmed illnesses, an increase from the three cases previously reported in June. All four infants required hospitalization, while no deaths have been reported.
According to the FDA, unopened samples collected from the same production lots consumed by the affected infants are currently undergoing laboratory testing. The agency said results are expected in the coming weeks.
State officials have also gathered opened formula containers from the homes of affected families. The California Department of Public Health detected Clostridium botulinum in one opened can of Nara Organics powdered infant formula associated with an outbreak case. The FDA said additional analyses are continuing, including testing of an unopened container from the same production lot.
The recalled formula was distributed nationwide between July 2025 and June 2026 through Target stores, Target.com, and Nara.com. The FDA said Nara Organics infant formula represents less than one percent of infant formula sold in the United States, adding that the recall is not expected to create supply shortages.
On June 13, Nara Organics agreed to recall all of its Whole Milk Organic Powdered Infant Formula after the FDA recommended a recall because of the severity of the illnesses and the epidemiological findings.
Health Officials Advise Parents to Stop Using the Recalled Formula
The FDA continues to advise parents and caregivers not to use Nara Organics Whole Milk Organic Powdered Infant Formula under any circumstances. The agency recommends seeking immediate medical care if an infant develops symptoms consistent with infant botulism after consuming the product.
According to the FDA, early symptoms often include constipation, poor feeding, loss of head control, and difficulty swallowing. The illness can progress to breathing difficulties and respiratory arrest, and symptoms may take several weeks to appear after formula ingestion.
The agency also advises families who still possess the recalled formula to photograph the container, record the lot number and use-by date, and consider keeping opened cans if an infant develops symptoms because state health departments may request the product for testing. The FDA recommends labeling the container “DO NOT USE,” storing it separately from other infant food for at least one month, and discarding any remaining formula afterward if no symptoms develop.
According to the FDA, investigators are also reviewing the product’s manufacturing and supply chain. During an earlier update, the agency reported that the lots linked to the illnesses were produced using milk supplied by Organic West Milk and spray dried by Dairy Farmers of America. The FDA noted that these suppliers were also involved in a separate 2025 infant botulism outbreak associated with ByHeart powdered infant formula, although the agency said there is currently not enough evidence to determine whether they represent the source or route of contamination in the present investigation.
