FDA investigates infant botulism outbreak linked to recalled baby formula

Four infants in California, Pennsylvania and Washington have confirmed botulism linked to Nara Organics Whole Milk Organic Infant Formula. All four infants were hospitalized and treated with BabyBIG, and no deaths have been reported. Families with the recalled formula at home should not feed it to any infant, and should watch for constipation, trouble feeding, a weak or altered cry and loss of muscle tone, the earliest signs of a rare but serious illness that can take several weeks to appear.

The recalled product was pulled from the market on June 13 after public health officials tied it to the illnesses. It was sold at Target stores, on Target.com and on Nara.com. Nara Organics formula makes up less than 1% of infant formula available in the United States, according to the CDC, so shortages are not expected, but infants exposed to the product should be monitored for a month after the last use because symptoms can emerge slowly. The infants were 2 to 5 months old when their illnesses began.

Laboratory testing confirmed Clostridium botulinum in an open can of the recalled formula that was fed to one of the infants, and the Food and Drug Administration is now testing an unopened sample from the same lot. The lots tied to the illnesses were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America.

Before this case cluster, the FDA had inspected and issued citations to two facilities that manufacture Nara formula, and corrective-action responses are still under review. The California Department of Public Health’s Infant Botulism Treatment and Prevention Program is providing no-cost clinical consultation and access to BabyBIG for physicians treating affected infants.

The CDC identified 48 total cases, 28 confirmed and 20 probable, across 17 states in an earlier infant formula botulism investigation centered on ByHeart, leading to a full recall of ByHeart Whole Nutrition infant formula.