Nara Organics has voluntarily recalled all lots of its powdered infant formula currently on the market due to the potential risk of Clostridium botulinum contamination, according to a company announcement.
The infants, located in California, Washington, and Pennsylvania, were hospitalized and treated with BabyBIG, a specialized treatment for infant botulism. No deaths have been reported, according to a statement released Saturday by the U.S. Food and Drug Administration.
The recall affects Nara Organics Whole Milk Infant Formula in 700-gram and 400-gram containers sold nationwide through Target stores, Target.com, and Nara.com between July 2025 and June 2026. Nara Infant Formula is not distributed outside the United States, according to the FDA.
“The health of all babies is our first priority, and for that reason, we’re issuing a voluntary recall for all cans of Nara Organics infant formula currently available in the U.S.,” the company stated Saturday. “Stop using all Nara Organics infant formula immediately. We are heartbroken for the concern and stress this may cause your family.”
The company said the FDA and the Centers for Disease Control and Prevention notified it on June 12 about three cases of infant botulism involving infants who reportedly consumed Nara formula.
Infant botulism is a rare but potentially life-threatening illness caused when Clostridium botulinum spores colonize an infant’s intestinal tract and produce toxins, according to the FDA. Symptoms can include constipation, poor feeding, drooping eyelids, difficulty swallowing, weakness, and respiratory problems.
Nara said its formula has not tested positive for C. botulinum as of June 13. However, the company is recalling all products currently in the market while it works with federal and state health officials to investigate the reported illnesses.
Consumers are advised to stop using the recalled formula immediately and contact a health care provider if an infant develops symptoms associated with botulism.
Nara said it conducts testing on every batch of formula that exceeds requirements established by the FDA and the European Union.
The company said each batch is screened for sulphite-reducing clostridia, a commonly used indicator in testing for Clostridium botulinum contamination, as well as other spore-forming bacteria, including Clostridium perfringens and Bacillus cereus. Nara said it also performs a broad range of additional microbiological testing on its products.
Nara will provide refunds to all consumers who purchased formula from their website in May 2026 and June 2026, the FDA said. Other customers with unused product may request a refund by taking a photo of the bottom of each can and completing the refund form.
The FDA said Saturday it was in the early stages of this investigation, and further testing by the FDA and state partners was underway.
