A multistate outbreak of infant botulism has prompted a nationwide recall of a specific powdered baby formula. Federal health officials are urging parents and caregivers to cease using the product immediately following the hospitalization of three infants.

According to the Centers for Disease Control and Prevention (CDC), the three cases spanning California, Pennsylvania, and Washington have been linked to the consumption of the same formula brand from Nara Organics. This has triggered an active, ongoing investigation by the CDC and the FDA, alongside state health departments, into the source and scope of the contamination.

"The health of all babies is our first priority, and for that reason, we’re issuing a voluntary recall for all cans of Nara Organics infant formula currently available in the U.S.," Nara Organics said in an email statement to Newsweek on Sunday, confirming that they were notified by the FDA about the botulism cases. "We are heartbroken for the concern and stress this may cause your family."

They added: "As of today, no Nara formula has tested positive for C. Botulinum. We believe in taking the strongest possible measure to protect the safety of babies. That’s why we quickly decided, in an abundance of caution, to voluntarily recall all Nara Organics infant formula currently available in the U.S."

Infant botulism is rare but can be severe or even fatal if not treated quickly. It occurs when babies ingest spores of Clostridium botulinum, a bacterium that produces toxins attacking the nervous system. All three infants affected in the June 2026 outbreak were hospitalized and required treatment, though no deaths have been reported.

The FDA said in an advisory that the formula makes up less than 1 percent of all infant formula sold in the country and noted the recall should not create a shortage.

The cases highlight ongoing safety concerns surrounding powdered infant formula, particularly after a separate outbreak linked to a different brand in late 2025 sickened dozens of infants nationwide. Public health officials emphasize that because symptoms can take several weeks to manifest, tracing the illness back to contaminated formula can be challenging for families.

What Are the Symptoms of Botulism in a Baby?

According to the CDC, the onset of infant botulism is typically subtle and progressive. Key symptoms include:

• Constipation: Frequently the earliest identifiable sign.
• Feeding Difficulties: Lethargy during feeding, or a noticeably weakened suck and swallow reflex.
• Altered Cry: A cry that sounds significantly weaker than usual.
• Hypotonia: Loss of head control or generalized "floppy" muscle tone.
• Facial Weakness: Drooping eyelids or a markedly diminished capacity for facial expression.
• Respiratory Distress: Difficulty breathing, which occurs as the toxin affects respiratory muscles in severe cases.

Public health officials urge families to seek immediate emergency medical evaluation if any of these symptoms present, as the condition can rapidly progress to paralysis and respiratory failure without intervention.

List of Recalled Baby Formula

Federal authorities have identified the current outbreak as originating from a single product line, which has now been fully recalled by the manufacturer:

Nara Organics Whole Milk Organic Infant Formula

• Scope: All lots and all sizes (400g and 700g cans).
• Distribution: Sold nationwide via Target retail locations, Target.com, and Nara.com.
• Specific Recalled Lot Codes:
  • 408125075E14F2 | 708125076E14F2 | 708125083E14F2
  • 708125174E14F2 | 709125273E14F2 | 709125280E14F2
  • 709125288E14F2 | 70926019ENNB | 70926029ENNB
  • 70926035ENNB | 70926039ENNB | 70926042ENNB

ByHeart Whole Nutrition (Prior 2025 Recall): Separately, federal officials previously linked Clostridium botulinum contamination to ByHeart Whole Nutrition infant formula, impacting products distributed between August 9 and November 13, 2025.

As of late November 2025, all 31 infants affected in that distinct cluster required hospitalization and received an intravenous antitoxin designated specifically for pediatric botulism cases. The FDA mandated a comprehensive market withdrawal of all compromised ByHeart inventory due to the systemic risk of bacterial contamination.

What Should Parents and Doctors Do?

Public health agencies advise parents and caregivers to discontinue the use of any recalled formula, and either dispose of the product securely or return it to the point of purchase.

If an infant has already consumed the recalled formula, they must be monitored closely for neurological or gastrointestinal symptoms for several weeks due to the extended incubation period of the bacterial spores. At the first sign of clinical abnormality—such as diminished feeding, generalized weakness, or dysphagia—parents should seek urgent medical care.

Doctors are advised to rely on clinical symptoms rather than waiting for lab confirmation and to begin treatment promptly, including administering the antitoxin therapy known as BabyBIG when appropriate. Public health authorities also urge clinicians to report suspected cases immediately to help track the outbreak and prevent further illnesses.