Product Safety Recall

Three Infants Hospitalized; Nationwide Recall Initiated 

Nara Organics has voluntarily recalled all lots of its powdered infant formula currently on the U.S. market following reports of three cases of infant botulism in infants who reportedly consumed the product. 

The recall was initiated after the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) notified the company of three infant botulism cases involving infants in California, Washington, and Pennsylvania. All three infants required hospitalization and treatment with BabyBIG® (Botulism Immune Globulin Intravenous). No deaths have been reported. 

Although Nara Organics formula has not tested positive for Clostridium botulinum to date, the company is recalling all products currently in commerce out of an abundance of caution while federal and state investigators continue to evaluate the cases. 

Recalled Products 

The recall affects all lots currently on the market of: 

Nara Organics Whole Milk Infant Formula (700g) 

• UPC: 860013251901 

Nara Organics Whole Milk Infant Formula (400g) 

• UPC: 860013251918 

The products were distributed nationwide from July 2025 through June 2026 through Target retail stores, Target.com, and Nara.com. 

What Is Infant Botulism? 

Infant botulism is a rare but potentially life-threatening illness caused when Clostridium botulinum spores colonize an infant’s intestinal tract and produce neurotoxins. 

Because infants have immature gastrointestinal systems, they are particularly vulnerable to colonization and toxin production. 

Symptoms may include constipation, poor feeding, weak sucking or swallowing, drooping eyelids (ptosis), sluggish pupils, low muscle tone (“floppy baby syndrome”), a weak or altered cry, generalized weakness, breathing difficulties, and respiratory arrest. 

Prompt medical evaluation is critical when symptoms are suspected. 

Cases Under Investigation 

According to FDA and CDC communications, the three hospitalized infants reportedly consumed formula associated with the following lots: 

• 709125280E14F2 

• 709125288E14F2 

• 708125174E14F2 

All three infants received BabyBIG therapy and survived. 

At the time of the recall announcement there were three reported illnesses and hospitalizations. No deaths had been reported.  

Federal and state investigators continue to evaluate the source and cause of the illnesses. 

Recommended Actions 

Parents and caregivers should stop using affected formula immediately, monitor infants for signs of botulism, contact their physician with any concerns, and seek immediate medical care if symptoms develop. 

Consumers may obtain refunds through Nara Organics or return affected products through Target’s return process. 

MDP Regulatory Perspective 

This recall highlights the exceptionally low tolerance for risk associated with infant nutrition products. 

Notably, the recall was initiated despite the absence of confirmed Clostridium botulinum findings in product testing. The decision reflects the severity of the potential hazard and the seriousness of the illnesses under investigation. 

The involvement of FDA, CDC, and multiple state health agencies underscores the importance of rapid public health response when potentially contaminated infant formula is linked to severe illness. 

For manufacturers, the event serves as a reminder that postmarket surveillance extends beyond product testing and includes epidemiological signals, adverse event reports, outbreak investigations, and coordination with public health authorities. 

For healthcare providers, early recognition of infant botulism symptoms remains critical, as prompt diagnosis and treatment can significantly improve outcomes.