FDA, CDC, and health officials in California, Pennsylvania, and Washington are examining the situation; food safety attorney Bill Marler describes it as the second formula-related infant botulism incident in seven months and repeats his call for the FDA and infant formula sector to take stronger action.

, /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), working alongside the California Department of Public Health (CDPH), the Infant Botulism Treatment and Prevention Program (IBTPP), and various state and local partners, are looking into a multistate outbreak of infant botulism associated with Nara Organics Whole Milk Organic Powdered Infant Formula. Three infants located in California, Pennsylvania, and Washington have fallen ill with type A botulinum toxin, with symptoms starting between April and May 2026. All three required hospital care. No fatalities have occurred.

On June 13, 2026, Nara Organics consented to recall its entire line of Nara Organics-brand Whole Milk Organic Powdered Infant Formula once the FDA suggested such a step given the gravity of the cases and the epidemiological connection. Per the FDA, the formula reached stores nationwide through Target retail locations, Target.com, and Nara.com from July 2025 through June 2026. The item originated in Europe. Parents and caregivers must discontinue its use right away.

What Parents and Caregivers Should Do Now

Inspect your pantry. Cease use of Nara Organics Whole Milk Organic Powdered Infant Formula at once.
Avoid discarding it immediately. Mark the container "DO NOT USE," take a photo of the label and lot details, and keep it isolated from other foods for a minimum of one month - your state health department could request it for testing.
Monitor for symptoms. Infant botulism typically starts with constipation, reduced feeding, a faint cry, poor head control, and swallowing issues, potentially advancing to breathing difficulties. Signs may emerge weeks after consumption.
Obtain medical help promptly if your infant exhibits any of these indicators. Botulism poses a risk of fatality, making timely intervention essential.
Doctors suspecting infant botulism should contact the IBTPP around the clock at 510-231-7600 for guidance on cases.
Clean any objects and surfaces that contacted the formula using hot, soapy water or a dishwasher.

Statement of William "Bill" Marler

"This marks the second instance in seven months where parents learn that the powdered formula they relied on for their baby might contain the toxin behind botulism - and again, the key component is whole milk powder, with the item once more stocked at Target. We have encountered this scenario previously. In March 2023, the FDA informed the full industry, in documented form and specifying Clostridium botulinum, that powdered infant formula carried a known record of botulism cases and that producers needed to manage this risk. None of these events came as a surprise. They could have been avoided."

"Three infants remain hospitalized. Thankfully, no lives have been lost. Yet a recall after illnesses occur does not constitute an effective food safety approach - it amounts to a poor response. Following the ByHeart incident, the FDA issued warning letters to Target, Walmart, Kroger, and Albertsons since recalled infant formula lingered on shelves - sometimes even restocked and marked down - weeks into the recall process. Thus, I seek clarity on what improvements have taken place. I question why finished formula undergoes botulism testing only after infants fall ill rather than prior to any shipment. And I ask why manufacturers face no requirement to notify the FDA when a baby recovers from a formula-related condition."

"My firm handles cases for over twenty additional families affected by the ByHeart outbreak - the initial recognized formula-linked infant botulism event. I have devoted more than thirty years to supporting parents during their most challenging moments, and an infant requiring ventilation represents a concrete reality. If this formula is in your possession, discontinue its use today - yet retain the container, as your health department might require it. And if your baby shows poor feeding, cannot support their head, or appears unusually weak or limp, act without delay. Reach your physician immediately."

A Familiar Pattern

This represents the second infant formula-linked botulism outbreak in the United States within under a year. During November 2025, the ByHeart Whole Nutrition Infant Formula incident affected 48 infants in 17 states. Whole-genome sequencing connected that event to Clostridium botulinum in organic whole milk powder. In the present Nara Organics situation, the product involved is likewise a whole-milk powdered formula.

About Infant Botulism

Infant botulism constitutes a uncommon yet severe condition triggered when Clostridium botulinum spores are swallowed, activate in an infant's developing digestive system, and generate a toxin that impacts the nervous system. Identified through clinical evaluation, it may advance from constipation and inadequate feeding to muscle weakness, diminished head control, and breathing failure. Most infants recover following swift treatment, including the antitoxin BabyBIG administered via the IBTPP, though recovery often involves extended hospital stays and critical care.

Official Resources

FDA outbreak advisory: Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026)
CDC food safety alert: Infant Botulism Outbreak - Infant Formula (June 2026)
Infant Botulism Treatment and Prevention Program: infantbotulism.org

About Marler Clark

Marler Clark, The Food Safety Law Firm, stands as the leading national practice handling cases for victims of foodborne illness. Established by William D. Marler - who initiated this work following the 1993 Jack in the Box E. coli incident - the firm has assisted thousands affected by E. coli, Salmonella, Listeria, botulism, and similar pathogens, securing over $900 million in recoveries. Marler Clark also publishes Food Safety News. The firm is available at 1 (206) 794-5043 or via email.

SOURCE Marler Clark, The Food Safety Law Firm