Another sick baby has been identified in a botulism outbreak linked to Nara Organics powdered infant formula.
The Centers for Disease Control and Prevention is reporting that there are now four patients in the outbreak from California, Pennsylvania and Washington.
The babies were between two and five months old when they became sick. All four have experienced paralysis and all have been hospitalized. The babies became sick in April and May. All four of the sick babies are male and all four were fed Nara Organics powdered infant formula.
State public health officials have collected leftover infant formula for testing. Laboratory testing results confirmed C. botulinum bacteria were present in an open can of Nara Organics infant formula that was fed to one of the infants in this outbreak. FDA is testing an unopened sample of formula from the same lot.
Additional product testing by FDA and state partners is ongoing with results expected in the coming weeks.
Prior to reports of the sick babies, the Food and Drug Administration inspected two foreign companies that manufacture and pack the implicated Nara Organics formula. Both companies were cited for food safety deficiencies and both have submitted corrective plans, which are under review.
The specific lots of Nara Organics infant formula consumed by infants involved in this outbreak were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America. These are the same suppliers of milk and milk powder from the 2025 outbreak linked to ByHeart infant formula. However, not enough information is available to determine whether these products were contaminated or caused the illnesses.
During the investigation into the 2025 outbreak, Organic West Milk provided FDA with an incomplete customer list. The list did not indicate that they supplied milk to manufacturers of Nara Organics infant formula.
On June 13, Nara Organics recalled all of its infant formula.
About infant botulism
Anyone who has fed the recalled product to their babies and seen symptoms of botulism poisoning should immediately seek medical attention. Symptoms can take days to weeks to appear after the formula is eaten.
Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (trouble sucking and swallowing), a weak or altered cry, and loss of muscle tone including babies inability to hold up their heads.
If untreated, the disease may progress, and symptoms may worsen to cause paralysis of specific muscles, including those used in breathing and those in the arms, legs, and the body from the neck to the pelvis area.
