Key points
- This outbreak is over.
- CDC, FDA, the California Department of Public Health Infant Botulism Treatment and Prevention Program, and public health officials in several states investigated a multistate outbreak of infant botulism linked to powdered infant formula.
- Epidemiologic, traceback, and laboratory data showed that Nara Organics Whole Milk Organic Infant Formula was contaminated and made infants sick.
- Data indicate a common source of contamination for this outbreak and a 2025 outbreak linked to ByHeart Whole Nutrition Infant Formula.
- Although this outbreak is over, powdered infant formula has a long shelf-life. If you still have any of the recalled infant formula from Nara Organics in your home, do not feed it to your infant. Throw it away.
Investigation details
CDC, public health and regulatory officials in several states, the Infant Botulism Treatment and Prevention Program (IBTPP) at the California Department of Public Health, and the U.S. Food and Drug Administration (FDA) collected different types of data to investigate a multistate outbreak of infant botulism. Infant botulism happens when a baby swallows Clostridium botulinum spores that then grow in the gut and make toxin.
Epidemiologic data
No new cases were added to the investigation since the previous update on July 6, 2026. Four cases of infant botulism are included in this outbreak.
Laboratory and traceback data
FDA provided an update on its ongoing investigation on August 27, 2026.
Highlights include:
- Laboratory findings: As part of this investigation, FDA and state partners collected clinical and leftover formula samples from patients included in this outbreak, as well as finished product samples and ingredient samples, for testing. Whole genome sequencing (WGS) analysis linked a patient sample from this outbreak to a patient sample, product samples, and an ingredient sample collected during the investigation of the 2025 infant botulism outbreak linked to ByHeart Whole Nutrition infant formula.
- Traceback findings: The matching WGS results indicate a common source of contamination. FDA's traceback investigation determined that the infant formulas sold by both Nara Organics and ByHeart were made with milk supplied by Organic West Milk and spray dried by Dairy Farms of America. Currently, FDA does not have enough evidence to determine whether the milk was contaminated before it was dried or during the drying process.
Public health actions
On June 13, 2026, Nara Organics recalled all of its infant formula. If you have any Nara Organics infant formula, do not use it. The investigation is ongoing.
Previous updates
Epidemiologic data
One case has been added to the investigation since the last update on June 26, 2026. All cases have been confirmed through laboratory testing.
As of July 6, 2026, 4 infants with confirmed infant botulism have been reported from 3 states: California (2), Pennsylvania (1), and Washington (1). Illnesses started on dates ranging from April through May 2026.
All 4 infants were hospitalized and treated with BabyBIG. No deaths have been reported. Infants ranged in age from 68 days (2 months) to 153 days (5 months) at onset of illness.
April–May 2026 (see timeline)
2–5 months at onset of illness
4 (100%) male
Nara Organics Whole Milk Organic Infant Formula
Laboratory and traceback data
State public health officials have collected leftover infant formula for testing. Laboratory testing results confirmed C. botulinum bacteria were present in an open can of Nara Organics infant formula that was fed to one of the infants in this outbreak. FDA is testing an unopened sample of formula from the same lot.
Additional product testing by FDA and state partners is ongoing with results expected in the coming weeks.
Highlights from FDA's investigation update
FDA provided an update on its ongoing investigation on June 26, 2026.
Highlights include:
- Recent inspections: Before this outbreak, FDA inspected and issued citations to two facilities that manufacture Nara Organics infant formula. Both firms have submitted corrective action responses to FDA, which are currently under review.
- Common suppliers: The specific lots of Nara Organics infant formula consumed by infants involved in this outbreak were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America. These are the same suppliers of milk and milk powder from the 2025 outbreak linked to ByHeart infant formula. However, not enough information is available to determine whether these products were contaminated or caused the illnesses.
- Incomplete information provided: During the investigation of the 2025 outbreak, Organic West Milk provided FDA with an incomplete customer list. The list did not indicate that they supplied milk to manufacturers of Nara Organics infant formula.
- Further investigation: FDA's work is ongoing to determine the root causes of this outbreak and whether any additional products could be affected.
Public health actions
On June 13, 2026, Nara Organics recalled all of its infant formula. If you have any Nara Organics infant formula, do not use it. The investigation is ongoing.
Epidemiologic data
No new cases have been added to the investigation since the initial notice was published on June 13, 2026. All cases have now been confirmed through laboratory testing. One illness onset date has been corrected. The correct illness onset date is May 20, 2026, instead of May 27, 2026.
Nara Organics Whole Milk Organic Infant Formula
Laboratory and traceback data
FDA, CDC, CDPH IBTPP, other state partners, and Nara Organics are testing opened cans of infant formula and collecting unopened samples from the lot numbers fed to the sick infants for testing.
Additional results are expected in coming weeks.
Public health actions
On June 13, 2026, Nara Organics recalled all of its infant formula. If you have any Nara Organics infant formula, do not use it. The public health investigation is ongoing.
Epidemiologic data
As of June 13, 2026, 3 infants with confirmed or suspected infant botulism have been reported from 3 states: California (1), Pennsylvania (1), and Washington (1). Laboratory confirmation for some cases is ongoing.
Illnesses started on dates ranging from April through May 2026. All 3 infants were hospitalized and treated with BabyBIG. No deaths have been reported.
Infants ranged in age from 86 days (2 months) to 153 days (5 months) at onset of illness.
State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they got sick. All (100%) reported feeding the infants Nara Organics infant formula.
Laboratory data
Federal and state public health departments are collecting and testing opened cans of infant formula and unopened product samples.
Testing is underway, and results are expected in coming weeks.
Public health actions
On June 13, 2026, Nara Organics recalled all of its infant formula. If you have any Nara Organics infant formula, do not use it. The public health investigation is ongoing.
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