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  5. Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026)
  1. Outbreaks of Foodborne Illness

Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026)

CDC declares outbreak has ended. FDA’s outbreak investigation identifies link to previous outbreak.

Nara Organics Organic Infant Formula

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Product

Recalled Nara Organics Whole Milk Organic Powdered Infant Formula. 

Recalled products should no longer be available for sale. Recalled product has “Best By” dates ending in 2027. Consumers should check their homes for any remaining recalled product and discard it. 

Symptoms of Infant Botulism

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. 

Stores Affected

Nara Organics Powdered Infant Formula was distributed nationally across Target retail stores, Target.com, and Nara.com between July 2025 and June 2026. Nara Organics infant formula is not distributed outside of the USA.

Status

The outbreak is over and the outbreak investigation has ended. 

Please see Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula for more information about FDA’s ongoing efforts to investigate this outbreak, with a focus on ingredients, and to ensure the safety of infant formula. The agency is now focused on post-incident response actions and activities, which include additional surveillance, as well as prevention and compliance activities.

Recommendations

  • Recalled products should no longer be available for sale. Recalled product has “Best By” dates ending in 2027. Consumers should check their homes for any remaining recalled product and discard it.
  • Wash items and surfaces (like bottles, counters, or formula dispensers) that may have touched the formula using hot soapy water or a dishwasher.
  • Botulism can be fatal. If your child has signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care.
  • If you are a Physician and suspect your infant patient has botulism, immediately call the Infant Botulism Treatment and Prevention Program at 510-231-7600 for case consultation. Consultation is available 24/7.

Current Update

August 27, 2026

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, investigated a multistate outbreak of four cases of infant botulism illnesses from three states: California, Pennsylvania, and Washington. The CDPH IBTPP reported four confirmed botulism cases among infants who consumed Nara Organics Whole Milk Organic Powdered Infant Formula with illness onset between April and May 2026. 

As of August 27, 2026, CDC has declared the outbreak over. No new cases have been added since July 3rd and as of August 27, the investigation includes 4 cases of confirmed infant botulism.

As part of this investigation, FDA and state partners collected samples from case patients included in this outbreak, as well as finished product samples and ingredient samples. The whole genome sequencing (WGS) analysis, or DNA fingerprinting of Clostridium botulinum, the toxin-producing bacteria causing illness, is summarized below: 

  • One clinical sample from an infant in this outbreak is a genetic match to the following: 
    • A clinical sample from an infant included in the 2025 ByHeart outbreak;  
    • A powdered infant formula base sample from the 2025 ByHeart outbreak investigation; and
    • Four samples of unopened cans of ByHeart powdered infant formula.

Based on information gathered in the current outbreak investigation, FDA determined that the Nara Organics infant formula lots linked to illnesses in this outbreak were made with milk supplied by Organic West Milk and spray dried by Dairy Farms of America. These are the same suppliers of organic whole milk and organic whole milk powder from the outbreak of infant botulism linked to ByHeart Powdered Infant Formula in November 2025. 

The matching WGS results linking an infant who consumed Nara infant formula with the previous outbreak linked to ByHeart infant formula and the supply chain commonalities indicate that there is a common source of contamination between the two outbreaks. Currently there is not enough evidence to determine if milk was contaminated before drying or during the drying process, and FDA’s root cause investigation is ongoing. 

FDA continues to work with the firms involved in both outbreaks and the infant formula industry to prevent future outbreaks. Additional updates regarding will be provided on FDA’s Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula webpage.

Case Count Map Provided by CDC

Map of states with cases. One case in Washington, One case in Pennsylvaia, One case in California.

Case Counts

Total Illnesses: 4
Hospitalizations: 4
Deaths: 0
Last Illness Onset: May 31, 2026 
States with Cases: CA, PA, WA
Product Distribution: Online and nationwide

Useful Links

Previous Updates

July 6, 2026

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of four cases of infant botulism illnesses from three states: California, Pennsylvania, and Washington. The CDPH IBTPP reported four infants with confirmed infant botulism, with illness onset between April and May 2026. All four infants included in this outbreak consumed Nara Organics Whole Milk Organic Powdered Infant Formula.

FDA has collected unopened samples from the lot numbers fed to the affected infants for testing. This testing is underway, and results are expected in the coming weeks. 

State officials have also collected infant formula from families of sick infants for testing. CDPH is one of the laboratories performing testing of opened cans of formula associated with outbreak cases. CDPH detected Clostridium botulinum in an opened can of Nara Organics powdered infant formula obtained from the home of one of the infants who got sick in this outbreak. Analyses are being conducted in addition to FDA’s analysis of the unopened sample from the same lot. 

FDA continues to work with the firms included in this investigation to determine the root cause of this outbreak and if any additional products are impacted. This advisory will be updated as information becomes available. 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.  

June 26, 2026

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of three confirmed infant botulism illnesses from three states: California, Pennsylvania, and Washington. The CDPH IBTPP reported three toxin type A infections among infants consuming Nara Organics Whole Milk Organic Powdered Infant Formula with illness onset between April and May 2026. All three cases included in this outbreak consumed Nara Organics-brand powdered infant formula. 

Officials in two states have collected leftover infant formula for testing. FDA has collected unopened samples from the lot numbers fed to the affected infants for testing. This testing is underway, and results are expected in the coming weeks.

Prior to learning of the illnesses, FDA conducted inspections at the two firms that manufacture Nara Organics Whole Milk Organic Infant Formula in Europe. At the conclusion of both inspections, observations citing deficiencies were issued to both facilities. Both firms have submitted corrective action responses to FDA, which are currently under review.

FDA is also in the process of conducting a traceback investigation and has determined that the Nara Organics infant formula lots linked to illnesses in this outbreak were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America. While these are the same suppliers of organic whole milk and organic whole milk powder from the outbreak of infant botulism linked to ByHeart Powdered Infant Formula in November 2025, currently there is not enough evidence to determine if this is the source or route of contamination.

Further, FDA conducted a traceforward investigation during the 2025 outbreak to determine if Organic West Milk supplied milk to any other powdered infant formula manufacturers. At that time, Organic West Milk provided an incomplete customer list that did not indicate that their milk was supplied to manufacturers of Nara Organics infant formula. As part of the current investigation, Organic West Milk informed FDA that the customer information previously provided was incomplete and should have included suppliers to Nara Organics. 

FDA continues to work with the firms included in this investigation to determine the root cause of this outbreak and if any additional products are impacted. The FDA has also been in contact with relevant European authorities. This advisory will be updated as information becomes available. 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.  

June 13, 2026

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of three confirmed or suspected infant botulism illnesses from three states: California, Pennsylvania, and Washington. The CDPH IBTPP reported three toxin type A infections among infants consuming Nara Organics Whole Milk Organic Powdered Infant Formula with illness onset between April and May 2026. All three cases included in this outbreak consumed Nara Organics-brand powdered infant formula. Officials in two states have collected leftover infant formula for testing. This testing is underway, and results are expected in the coming weeks. 

On June 12, 2026, FDA contacted the firm to notify them about this outbreak and recommended that the firm conduct a recall due to the severity of illness 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. 

FDA’s investigation is ongoing. This advisory will be updated as information becomes available. 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. 

Who to Contact

Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.

To report a complaint or adverse event (illness or serious allergic reaction),
visit Industry and Consumer Assistance.

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