TL;DR: Nara Organics imported its recalled Whole Milk Organic Infant Formula from Germany but has not named the German manufacturer, as federal officials investigate three infant botulism cases in California, Pennsylvania and Washington.

Newest verified fact: importer will not name maker

Nara Organics, of New York, NY, sold infant formula linked to infant botulism that was imported from Germany, according to Food Safety News. The company has not named the specific German manufacturer of the formula.

"Nara works with a state of the art manufacturer in Germany who has over 70 years of experience making top European infant formulas," a company spokeswoman told Food Safety News. That report, published June 17, 2026, said the spokeswoman did not respond to questions about the name of the German manufacturer nor provide comment about why the name was being withheld from the public.

The lack of a named manufacturer leaves parents, retailers and health departments with only the U.S. brand name and lot codes to identify cans. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) contacted Nara Organics late Friday, June 12, 2026, and provided information about three cases of infant botulism in infants who CDC reported had consumed Nara formula, according to the FDA recall announcement posted June 13, 2026.

Nara Organics agreed on June 13, 2026, to recall all Nara Organics brand Whole Milk Organic Powdered Infant Formula after FDA recommended a recall because of the severity of illnesses and the epidemiologic signal, according to Food Safety News. Consumers should not use recalled infant formula.

Three infants hospitalized in three states

As of June 13, 2026, a total of three infants with infant botulism had been reported in the outbreak from three states: California, Pennsylvania, and Washington, according to the CDC newsroom release dated June 13, 2026. They ranged in age from 2 to 5 months when their illness began. All three consumed Nara Organics Whole Milk Organic Infant Formula.

The California Department of Public Health reported that the infections were among infants who were fed Nara Organics Whole Milk Organic Powdered Infant Formula, according to Food Safety News. The babies became sick in April and May.

All three infants were hospitalized and treated with BabyBIG®, the FDA-approved treatment for infant botulism, according to the CDC release. The FDA recall announcement said the three infants were hospitalized and treated with BabyBIG (Botulism Immune Globulin Intravenous) in California, Washington, and Pennsylvania. No deaths have been reported.

The Washington State Department of Health said a Thurston County infant recently diagnosed with infant botulism consumed Nara Organics whole milk infant formula prior to onset of symptoms. The department listed its state count as one case, one hospitalization and zero deaths, with status ongoing and recall yes, in its update last updated June 15, 2026.

Infant botulism happens when swallowed spores from Clostridium botulinum bacteria infect a baby's large intestine and make toxin in it, according to the CDC release. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding, including sucking and swallowing problems, a weak and altered cry, and lack of head control.

The FDA recall announcement described infant botulism as a rare but potentially fatal illness that occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. It listed signs and symptoms that can include constipation, poor feeding, ptosis, sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest.

National recall covers all lots on the market

Nara Organics of New York, NY, is voluntarily recalling all lots of Nara Organics Powdered Infant Formula currently on the market out of an abundance of caution due to the potential risk of Clostridium botulinum contamination, according to the FDA recall announcement.

Nara Organics Powdered Infant Formula was distributed nationally across Target retail stores, Target.com, and Nara.com between July 2025 and June 2026, according to the FDA announcement. The implicated organic formula was distributed nationally across Target retail stores, Target.com, and Nara.com between July 2025 and June 2026, according to Food Safety News. Nara Infant Formula is not distributed outside of the USA, according to the FDA announcement.

Affected product details listed by FDA are Nara Organics Whole Milk Infant Formula, 700g, with UPC 860013251901, and Nara Organics Whole Milk Infant Formula, 400g, with UPC 860013251918. All lots currently on the market are included in the voluntary recall.

The lot code can be found on the bottom of each can. The specific codes listed are 408125075E14F2, 708125076E14F2, 708125083E14F2, 408125139E14F2, 708125141E14F2, 708125145E14F2, 708125174E14F2, 709125273E14F2, 709125280E14F2, 709125288E14F2, 409125307E14F2, 70926019ENNB, 70926029ENNB, 70926035ENNB, 70926039ENNB, and 70926042ENNB.

The three specific product lots these infants were exposed to are 709125280E14F2, 709125288E14F2, and 708125174E14F2, according to the FDA announcement. To date, Nara infant formula has not tested positive for C. botulinum, but Nara is voluntarily recalling all products currently in market, the announcement said.

Officials in two states have collected leftover infant formula for testing, according to Food Safety News. Testing of opened cans of Nara Organics brand formula and unopened Nara Organics product samples is underway, and results are expected in the coming weeks, according to the CDC release.

Nara Organics Whole Milk Organic Infant Formula makes up less than 1 percent of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers, according to the FDA, as reported by Food Safety News.

Nara will automatically refund all consumers who purchased formula from their website in May and June 2026, according to the FDA announcement. Other customers with unused product may request a refund by taking a photo of the bottom of each can and completing a refund form, while Target customers may return their product to Target retail locations or follow Target's online return instructions.

Lawmaker calls for Infant Formula Safety Modernization Act

A U.S. representative issued a statement on June 16 calling on Congress to pass the bipartisan Infant Formula Safety Modernization Act, according to Food Safety News. That representative was Rep. Rosa DeLauro, D-CT.

"In just seven months, we have experienced two outbreaks of infant botulism tied to powdered infant formula. First, a ByHeart outbreak which sickened 48 sick babies across 19 states, and now Nara Organics with babies in three different states – all of them between two and five months old – now fighting for their lives," DeLauro said in the statement quoted by Food Safety News.

"This is not an isolated incident, it is a concerning pattern that begs the question; are we doing enough to ensure the safety of infant formula in this country? Before ByHeart and Nara Organics, in 2022, there was Abbott's facility in Sturgis, MI, that shutdown after a cronobacter sakazakii outbreak, triggering a nationwide shortage that left families scrambling for formula and babies hospitalized and in some cases, dead," DeLauro said.

"The food we give our babies must meet the highest standard of safety. Right now it does not, and the gaps in the system are clear. Multiple crises year after year show the current system is not working, and we must be doing more," DeLauro said.

The Infant Formula Safety Modernization Act is endorsed by the American Academy of Pediatrics, Consumer Reports, Prolacta, Consumer Federation of America, Environmental Working Group, Center for Science in the Public Interest, STOP Foodborne Illness, and the Association of Public Health Laboratories, according to Food Safety News.

Prior outbreaks sharpen scrutiny of powdered formula

The ByHeart outbreak sickened 48 babies across 19 states, according to DeLauro's statement. Seattle food safety attorney Bill Marler said his firm represents more than twenty other families whose infants were poisoned in the ByHeart outbreak — the first formula-linked infant botulism outbreak ever recognized, according to Food Safety News.

"We have been here before," Marler said, as quoted by Food Safety News. "In March 2023, the FDA told this entire industry, in writing and naming Clostridium botulinum, that powdered infant formula had a documented history of botulism and that manufacturers had to control for it. None of this was unforeseeable. It was preventable."

Marler said three babies were in the hospital and mercifully no one had died, but a recall after the fact is not a food safety system. After the ByHeart outbreak, the FDA had to send warning letters to Target, Walmart, Kroger and Albertsons because recalled infant formula was still sitting on store shelves — in some cases restocked and discounted — weeks after the recall began, Marler said, according to Food Safety News.

What parents, caregivers and clinicians are told to do

Parents and caregivers are urged to immediately stop using any Nara Organics Whole Milk Organic Infant Formula, according to the CDC release. Consumers should not use recalled infant formula, according to Food Safety News. Customers should stop using the affected products immediately, according to the FDA announcement.

If you have unopened cans of Nara Organics infant formula, throw them away or return them, according to the CDC release. If you have leftover opened cans, take a picture and record the lot number and use-by date, consider retaining any opened formula because the state health department may want to test it if illness develops, label it "DO NOT USE" and keep it stored in a safe place away from other items fed to the baby for at least a month, and if no symptoms appear after a month, throw the leftover formula away.

Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher, according to CDC and FDA guidance. To report an illness or adverse event, use FDA's Safety Reporting Portal, with the FDA announcement also listing SmartHub reporting and Voluntary MedWatch forms online or by mail.

Seek immediate health care if an infant consumed Nara Organics brand infant formula and has poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, according to the CDC release. Symptoms of infant botulism can take several weeks to start, and parents should watch an exposed infant for symptoms for a month after the infant last consumed the product.

For clinicians, initial diagnosis of infant botulism is based on clinical signs, and if clinical consultation supports infant botulism, begin treatment as soon as possible without waiting for laboratory confirmation, according to the CDC release. Treatment with BabyBIG® is recommended for all suspected cases. Customers with questions are encouraged to visit Nara's website or email [email protected], according to the FDA announcement.

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