Infant formula recalled after suspected multistate outbreak of infant botulism
The FDA announced the recall of Nara Organics Whole Milk Organic Powdered Infant Formula on Saturday, with cases under investigation in California, Pennsylvania, and Washington.
A brand of infant formula sold nationwide is being recalled after three confirmed or suspected cases of infant botulism.
The recall of Nara Organics Whole Milk Organic Powdered Infant Formula was announced by the FDA on Saturday, with cases under investigation in California, Pennsylvania, and Washington.
Nara Organics Powdered Infant Formula was distributed through Target retail stores and its online shop, as well as on Nara.com, between July 2025 and June 2026.
Three toxin type A infections were reported among infants who consumed the formula, with illness onset occurring between April and May 2026, officials said.
The FDA and CDC contacted Nara Organics on June 12 to provide information about the three cases of infant botulism in infants who the CDC reported had consumed Nara formula.
To date, Nara infant formula has not tested positive for C. botulinum, the company said in a press release. Nara issued a voluntary recall for all products currently on the market on June 13.
Infant botulism is a rare but serious illness caused by spores of the bacterium Clostridium botulinum.
These spores are naturally found in the environment and can enter manufacturing facilities and homes through hands, shoes, and other contaminated surfaces.
Most infants with botulism initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to breathing difficulties and respiratory arrest, according to the FDA.
Symptoms can take several weeks to develop after consuming contaminated formula.
Officials say that the infant formula was manufactured in Europe.
On June 3, the FDA completed on-site inspections of ByHeart, another infant formula brand previously linked to an outbreak of infant botulism that began in November last year.
The FDA declared the ByHeart-related outbreak over on February 26.
In that outbreak, there were 28 confirmed cases of infant botulism and 20 probable cases across 17 states, including New Jersey. There were no deaths.
Both Nara Organics Whole Milk Organic Infant Formula and ByHeart Whole Nutrition Infant Formula products account for less than 1% of all infant formula sold in the United States.
For more information, visit the FDA’s webpage on Clostridium botulinum illnesses associated with powdered infant formula.
