Nara Organics has initiated a nationwide recall of all lots of its powdered infant formula currently on the US market because of a link with botulism cases.
According to the Food and Drug Administration (FDA) and the Center for Disease Control (CDC), three botulism cases have been reported in babies from consuming 'Nara Organics Whole Milk Organic Infant Formula'.
The CDC said the cases were reported in California, Pennsylvania and Washington in babies aged from two to five months. No deaths have been reported.
In a statement published on the FDA website, the New York-based business said the recall was initiated "out of an abundance of caution due to the potential risk of Clostridium botulinum contamination".
The affected products are Nara Organics Whole Milk Organic Infant Formula in 700g and 400g packs, sold through Target stores, Target.com and Nara.com between July 2025 and June 2026.
The formula is not sold outside the US. Nara Organics said the FDA and CDC contacted the company on Friday, 12 June.
In the statement, Nara Organics said it is “taking aggressive action to ensure the safety of the babies and families who use the product as we work closely with the FDA, CDC, and state partners to support their investigation into the root causes of these cases”.
Infant botulism is a rare but serious illness in which ingested spores colonise an infant’s immature gut and produce neurotoxins.
Symptoms can include constipation, poor feeding, drooping eyelids, swallowing difficulties, weakness and breathing problems.
The recall comes months after a separate botulism outbreak tied to ByHeart baby formula.
In February, the CDC said that outbreak had ended, although federal efforts to identify the root cause were still under way at the time.
The FDA confirmed at that point that no new cases had been reported since 10 December.
That investigation covered 28 confirmed and 20 probable cases, with no deaths reported.
ByHeart had recalled all infant formula products, including cans and single-serve sticks, after contamination of ByHeart Whole Nutrition powdered infant formula with Clostridium botulinum toxin Type A.
In January, the FDA said it had linked the outbreak to a supplier to ByHeart, without naming the company.
ByHeart said then that it continued to “cooperate fully” with regulators.
The latest Nara recall follows broader concerns this year over infant-formula safety.
In February, European authorities said the likelihood of exposure to formula contaminated with the cereulide toxin was “low” after extensive recalls across Europe that began in December and accelerated through January.
Nestlé, Danone and Lactalis were among manufacturers that withdrew infant formula due to concerns over cereulide, a toxin associated with the Bacillus cereus bacteria, which can trigger vomiting, abdominal cramps and diarrhoea.
EU agencies said additional cases could still arise if recalled products remained in homes. Investigators traced the source to an arachidonic acid oil supplier in China.
Nestlé, Lactalis and Danone, along with smaller producers Babybio and La Marque en Moins, are under investigation by the Paris prosecutor’s office in connection with the recall.
French authorities said deaths had been reported during the episode, but no causal link to the formula had been established.
