The U.S. company that sold the infant formula implicated in the recent outbreak of infant botulism imported the product from Germany.
However, Nara Organics did not specify the specific manufacturer of the formula.
“Nara is working with a cutting-edge German manufacturer with more than 70 years of experience in creating Europe’s best infant formula,” a company spokesperson said. food safety news.
A spokesperson did not respond to questions about the German manufacturer’s name or comment on why the name was not released to the public.
So far, the outbreak has sickened three babies in three states: California, Pennsylvania and Washington, according to the Food and Drug Administration. They were between 2 and 5 months old when the disease began. All three consumed Nara Organic Whole Milk Organic Infant Formula.
All three infants were hospitalized and treated with BabyBIG®, an FDA-approved treatment for infant botulism. No deaths were reported.
The U.S. representative issued a statement on June 16 urging Congress to pass the bipartisan Infant Formula Safety Modernization Act.
“In just seven months, we’ve had two outbreaks of infant botulism linked to formula. The first was the ByHeart outbreak that sickened 48 sick babies in 19 states, and now Nara Organics is raising babies in three different states, all between 2 and 5 months old, now fighting for their lives,” said Rep. Rosa DeLauro, D-CT.
“This is not an isolated incident, but a concerning pattern that raises questions: Are we doing enough to ensure the safety of infant formula in this country? ByHeart and Nara Organics previously had an Abbott facility in Sturgis, Michigan, closed in 2022 after a Cronobacter sakazakii outbreak, sparking a nationwide shortage that left families scrambling to buy formula and babies being hospitalized and, in some cases, dying.
“The food we feed our babies must meet the highest safety standards. This is not the case now and the gaps in the system are clear. Multiple crises each year show that the current system is not working and we need to do more.”
The Infant Formula Safety Modernization Act has been 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 Food Poisoning, and the Association of Public Health Laboratories.
Outbreaks and Recalls
The California Department of Public Health reported an outbreak of infections among infants fed Nara Organics whole milk organic formula. Babies got sick in April and May.
The related organic formulation was distributed nationally to Target retail stores, Target.com and Nara.com from July 2025 to June 2026.
Officials in both states collected leftover infant formula for testing. This testing is ongoing and results are expected in the coming weeks.
The FDA contacted the company and recommended a recall given the severity and epidemiological signs of the disease. On June 13, 2026, Nara Organics agreed to recall all Nara Organics brand whole milk organic infant formula. Consumers should not use recalled infant formula.
Affected product details:
- Nara Organic Whole Milk Infant Powder, 700g, UPC 860013251901
- Nara Organic Whole Milk Infant Powder, 400 g, w/ UPC: 860013251918
This recall includes all lots currently on the market, and the specific codes are as follows: The lot code can be found on the bottom of each can.
- 408125075E14F2
- 708125076E14F2
- 708125083E14F2
- 408125139E14F2
- 708125141E14F2
- 708125145E14F2
- 708125174E14F2
- 709125273E14F2
- 709125280E14F2
- 709125288E14F2
- 409125307E14F2
- 70926019ENNB
- 70926029ENNB
- 70926035ENNB
- 70926039ENNB
- 70926042ENNB
According to the FDA, Nara Organics whole milk organic infant formula accounts for less than 1% of all infant formula sold in the United States, and the outbreak does not cause infant formula shortages for parents and caregivers.
Thoughts from a food safety expert
Seattle food safety attorney Bill Marler said this pattern is more than troubling.
“We’ve been here before,” Marler said. “In March 2023, the FDA wrote the industry-wide name Clostridium botulinum, saying there was a documented history of botulism in powdered infant formula and that manufacturers should control it. None of this was unforeseen. It was preventable.
“Three babies are in the hospital. Fortunately, no one died. But recalls after the fact are not part of the food safety system. That’s a bad apple. After the ByHeart incident, the FDA had to send warning letters to Target, Walmart, Kroger and Albertsons because the recalled infant formula was still sitting on store shelves weeks after the recall began. In some cases, it had been restocked and discounted. So I want to know what has changed. I want to know why they test, and why manufacturers are not required to tell the FDA at all when a baby survives a formula-related illness.
“Our firm represents more than 20 families whose infants were poisoned in the ByHeart incident. This is the first ever outbreak of infant botulism associated with formula. I have been through the worst day of my life with a parent for over 30 years, and there is nothing abstract about an infant being on a ventilator. If you have this formula at home, stop using it today, but save the container as your health department may need it. And if your baby is not feeding well, he or she is unable to raise his or her head or appears unusually weak. If you’re floppy, don’t wait – call your doctor now.”
For more information about FDA’s ongoing efforts to ensure the safety of infant formula, see FDA’s Clostridium botulinum disease associated with consumption of infant formula web page.
