State and federal public health officials are investigating a new outbreak of infant botulism poisoning.
So far the outbreak has sickened three babies across three states: California, Pennsylvania and Washington, according to the Food and Drug Administration.
The California Department of Public Health has reported that the infections are among infants who were fed Nara Organics Whole Milk Organic Powdered Infant Formula. The babies became sick in April and May. They ranged in age from 2 to 5 months old when their illness began. All three consumed Nara Organics Whole Milk Organic Infant Formula.
All three infants were hospitalized and treated with BabyBIG®, the FDA-approved treatment for infant botulism. No deaths have been reported.
The implicated organic formula was distributed nationally across Target retail stores, Target.com, and Nara.com between July 2025 and June 2026.
Officials in two states have collected leftover infant formula for testing. This testing is underway, and results are expected in the coming weeks.
The FDA contacted the firm and recommended that it conduct a recall because of the severity of illnesses and the epidemiological signal. On June 13, 2026, Nara Organics agreed to recall all of their Nara Organics brand Whole Milk Organic Powdered Infant Formula. All of Nara Organics' formula was manufactured in Europe. Consumers should not use recalled infant formula.
Affected Product Details:
- Nara Organics Whole Milk Infant Formula, 700g, with UPC 860013251901
- Nara Organics Whole Milk Infant Formula, 400g, with UPC: 860013251918
All lots currently on the market are included in this recall, 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
Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.
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.
This is the second infant formula-linked botulism outbreak in the United States in less than a year. In November 2025, the ByHeart Whole Nutrition Infant Formula outbreak sickened 48 infants across 17 states. Whole genome sequencing tied that outbreak to Clostridium botulinum in organic whole milk powder. In the current Nara Organics outbreak, the implicated product is again a whole-milk powdered formula.
Seattle food safety attorney Bill Marler said the pattern is more than troubling.
“For the second time in seven months, parents are being told that the powdered formula they trusted to feed their baby may carry the toxin that causes botulism — and once again, the implicated ingredient is whole milk powder, and once again the product was on the shelves at Target," Marler said. "We have been here before. 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.
“Three babies are in the hospital. Mercifully, no one has died. But a recall after the fact is not a food safety system — it is a bad apology. 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. So, I want to know what has changed. I want to know why we test finished formula for botulism only after babies get sick instead of before a single can ships. And I want to know why, when a baby survives a formula-related illness, the manufacturer is under no obligation to tell the FDA at all.
“My firm represents more than twenty other families whose infants were poisoned in the ByHeart outbreak — the first formula-linked infant botulism outbreak ever recognized. I have spent more than thirty years sitting with parents on the worst day of their lives, and there is nothing abstract about an infant on a ventilator. If you have this formula in your home, stop using it today — but keep the container, because your health department may need it. And if your baby is feeding poorly, can’t hold up their head, or seems unusually weak or floppy, do not wait. Call your doctor now.”
For more information about FDA’s ongoing efforts to ensure the safety of infant formula please see FDA’s Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula webpage.
