FDA Investigates Second Infant Botulism Outbreak Linked to Organic Powdered Formula in Seven Months
核心洞察
Three infants across California, Pennsylvania, and Washington were hospitalized with botulism after consuming Nara Organics (搜索) Whole Milk Organic Powdered Infant Formula, with illness onset in April and May 2026.
Nara Organics (搜索) issued a nationwide recall on June 13, 2026, covering all lots of its whole milk powdered formula distributed through Target stores and online between July 2025 and June 2026.
This marks the second infant formula-linked botulism outbreak in less than a year, following the ByHeart outbreak in November 2025 that sickened 48 infants across 17 states.
State and federal public health officials are investigating a new multistate outbreak of infant botulism (搜索) linked to Nara Organics (搜索) Whole Milk Organic Powdered Infant Formula, the second such outbreak tied to whole-milk powdered formula in the United States in less than a year.
As of June 13, 2026, three infants from California, Pennsylvania, and Washington have been confirmed or are suspected to have infant botulism (搜索) after consuming the implicated formula. All three were hospitalized and treated with BabyBIG, the FDA-approved treatment for infant botulism. No deaths have been reported. The infants ranged in age from 86 days (2 months) to 153 days (5 months) at illness onset, with symptoms beginning in April and May 2026.
Recall and Product Distribution
On June 13, 2026, Nara Organics (搜索) agreed to recall all lots of its Whole Milk Organic Powdered Infant Formula after the FDA contacted the firm on June 12 and recommended a recall based on the severity of illnesses and the epidemiological signal. The recalled product was distributed nationally across Target retail stores, Target.com, and Nara.com between July 2025 and June 2026. All of Nara Organics' formula was manufactured in Europe.
The recall covers both the 700g (UPC 860013251901) and 400g (UPC 860013251918) sizes. Seventeen specific lot codes, found on the bottom of each can, are included in the recall. According to the FDA, Nara Organics (搜索) Whole Milk Organic Infant Formula represents less than 1 percent of all infant formula sold in the United States, and the outbreak is not expected to create shortage concerns.
Epidemiological and Laboratory Investigation
CDC, public health and regulatory officials in several states, the California Department of Health Infant Botulism (搜索) Treatment and Prevention Program (CDPH IBTPP), and the FDA are collecting data to investigate the outbreak. State and local public health officials are interviewing caregivers about foods fed to the infants in the month before illness onset; all (100%) reported feeding the infants Nara Organics (搜索) infant formula.
Officials in two states have collected leftover infant formula for testing, and federal and state public health departments are also testing unopened product samples. Laboratory confirmation for some cases remains ongoing, with results expected in the coming weeks.
Clinical Presentation
Infant botulism (搜索) typically presents with constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms can take as long as several weeks to develop following formula ingestion.
A Troubling Pattern
This outbreak follows the ByHeart Whole Nutrition Infant Formula outbreak in November 2025, which 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 (搜索) outbreak, the implicated product is again a whole-milk powdered formula.
Seattle food safety attorney Bill Marler, whose firm represents more than twenty families affected by the ByHeart outbreak, described the pattern as "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."
Marler raised pointed questions about the regulatory framework: "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."
He also highlighted post-recall failures from the ByHeart outbreak, noting that the FDA had to send warning letters to Target, Walmart, Kroger, and Albertsons because recalled infant formula remained on store shelves weeks after the recall began — in some cases restocked and discounted.
"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," Marler said. He urged parents: "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."