Infant formula brand Nara Organics has issued a voluntary recall of all its products sold in the US after the FDA and CDC linked its formula to three confirmed cases of infant botulism.
The US regulator notified the Europe-based manufacturer late Friday that three infants who had consumed Nara's powdered formula had been hospitalised in California, Washington and Pennsylvania. No fatalities have been reported.
The FDA confirmed the cases on 13 June 2026.
The recall covers all Nara Organics Whole Milk Infant Formula — available in 700g (UPC 860013251901) and 400g (UPC 860013251918) formats — sold through Target stores, Target.com and Nara.com between July 2025 and June 2026.
The product was not distributed outside the US.
Nara Organics stated that none of its formulas tested positive for Clostridium botulinum, the spore-forming bacterium responsible for infant botulism, but said it was acting "in an abundance of caution."
The FDA did note that Nara Organics accounts for less than one per cent of infant formula sold in the US; thus, the recall is not expected to affect the national formula supply.
The Nara recall is the latest in a series of infant formula safety incidents that Nutraceutical Business Review has tracked during the past six months.
In January 2026, the FDA confirmed that ByHeart Whole Nutrition powdered infant formula was the source of a multistate C. botulinum outbreak — the first documented botulism outbreak in the US attributed to contaminated infant formula — after positive test results were identified in finished product samples and an organic whole milk powder ingredient.
Around the same time, a separate contamination crisis was unfolding in Europe, where Nestlé, Lactalis and Danone each recalled batches of infant formula following the detection of cereulide, a toxin produced by Bacillus cereus and linked to a common external ingredient supplier.
French authorities opened two criminal investigations into infant deaths linked to the recalled products.
Taken together, the incidents point to mounting pressure on manufacturers, regulators and ingredient suppliers to strengthen traceability and contamination controls across the global infant nutrition supply chain.
Parents and caregivers who have purchased Nara Organics formula are advised to stop use immediately and follow FDA guidance on product returns.
Those whose infants have shown symptoms consistent with botulism — including constipation, weak cry, floppiness or feeding difficulties — are instructed to seek medical attention.