Nara Organics Recalls Infant Formula After Three Botulism Cases

Federal health officials are investigating a multistate outbreak of infant botulism linked to Nara Organics Whole Milk Organic Powdered Infant Formula, prompting the manufacturer to voluntarily recall all of its whole milk organic powdered formula products. Three infants in California, Pennsylvania, and Washington were diagnosed with toxin type A infections after consuming the formula in April or May. They were hospitalized and treated with the FDA-approved treatment for infant botulism. Infant botulism is a rare but serious illness that occurs in babies under age 1, whose gut microbiomes are immature; it is caused when infants consume bacteria with spores that produce a toxin in the gut. The sole treatment is BabyBIG, an IV medication made from blood plasma of people immunized against botulism.

Nara Organics Powdered Infant Formula was distributed nationally across Target retail stores, Target.com and Nara.com between July 2025 and June 2026 and is not distributed outside the U.S. All lots now for sale are included in the voluntary recall, which was initiated after notification from the FDA. The formula is manufactured in Europe but sold only in the U.S. The FDA urged parents to stop using the affected products immediately. Symptoms of infant botulism include constipation, poor feeding, drooping eyelids, weak muscle tone, difficulty swallowing, breathing problems, vomiting and diarrhea. The FDA said the brand accounts for less than 1% of the U.S. formula market, and the outbreak does not create shortage concerns for parents and caregivers. The CDC recommended that anyone with an opened can take a picture, record the lot number and use-by date, label it “DO NOT USE,” and keep it stored in a safe place away from other items you feed your baby for at least a month; if no symptoms appear after a month, the leftover formula should be thrown away.

The outbreak follows another infant botulism outbreak linked to ByHeart formula last year. The FDA has matched Clostridium botulinum isolates from the organic whole milk powder supplied to ByHeart with samples from closed cans of formula and affected infants. It is not clear how the contamination of ByHeart’s whole milk powder, made by Organic West Milk and processed by a Dairy Farmers of America plant, occurred. Companies are not currently required to test for C. bot, which has historically been rarely found in formula. Food safety experts say they want regulators and the industry to take even stronger measures to prevent disease outbreaks, and they caution there is no evidence that marketing claims such as organic, GMO-free, or added probiotics have any health effect on babies.

Separately, federal records show that the FDA has no record of a single notification from infant formula manufacturers about babies who died after using their products going back more than 26 years. Federal regulations give manufacturers discretion in deciding whether and when to notify the FDA that a product may have contributed to a serious adverse event. An analysis of federal data estimated that approximately 2,300 newborns died from necrotizing enterocolitis (NEC) in the United States between 2017 and 2023. More than 1,700 lawsuits have alleged that formula made by Abbott (Similac) and Mead Johnson (Enfamil) caused or contributed to these deaths, and as of late January 2026 approximately 1,760 NEC lawsuits were pending against Abbott alone. The FDA does not approve infant formula products before they reach market.

In a new government survey of infant formula, the FDA tested 312 samples and detected five per- and polyfluoroalkyl substances (PFAS). The most common one, PFOS, was found in half of all samples, with 95% of those samples containing less than 2.9 ppt of PFOS. PFOA was not detected in any formula, and PFOS was detected at a maximum concentration of 6 ppt. About 60% of dairy-based formulas tested contained PFOS, while powdered soy-based formulas tended to contain PFBA, a short-chain PFAS. The big takeaway from the survey is that the U.S. formula supply is largely safe.

In a separate recall, IF Copack LLC, doing business as Initiative Foods, recalled one lot of Tippy Toes brand Apple Pear Banana fruit puree because of elevated levels of patulin, a mycotoxin produced by molds that grow in fruits including apples. The product was distributed nationwide in all U.S. states other than Alaska and may have been distributed in Guam and Puerto Rico. The recalled product has a UPC of 036800265783, lot number 07174, a best-by date of July 17, 2026, and package code INIA0120. It was sampled under the Total Diet Study by the FDA, which found elevated patulin levels higher than is common for these products. No illnesses connected to the recall have been reported.