FDA and CDC investigating multistate infant botulism outbreak linked to recalled Nara Organics powdered infant formula

Three infants across 3 states have been hospitalized following diagnosis with infant botulism, all with confirmed exposure to Nara Organics Whole Milk Organic Powdered Infant Formula, prompting a full voluntary recall on June 13, 2026. The outbreak marks the second time in less than a year that powdered infant formula has been implicated in a multistate infant botulism investigation.¹

The cases—in California, Pennsylvania, and Washington—were reported to the CDC by the California Department of Public Health's (CDPH) Infant Botulism Treatment and Prevention Program (IBTPP), which identified toxin type A infections with illness onset between April and May 2026.² All 3 infants were hospitalized and treated with BabyBIG (Botulism Immune Globulin Intravenous), the only FDA-approved treatment for infant botulism caused by botulinum neurotoxin types A and B.³ No deaths have been reported.

Nara Organics stated: "Nara is taking aggressive action to ensure the safety of the babies and families who use the product as we work closely with the FDA, Centers for Disease Control and Prevention (CDC), and state partners to support their investigation into the root causes of these cases."¹

Epidemiological signal and recall timeline for Nara Organics infant formula

The FDA contacted Nara Organics on June 12, 2026, notifying the company of the outbreak and recommending a recall given the severity of illness and epidemiological evidence.² The following day, the company agreed to recall all lots of its Whole Milk Organic Powdered Infant Formula currently on the market, the first product-wide recall action taken by this manufacturer.

As of the time of this report, no lots of Nara Organics Powdered Infant Formula have tested positive for Clostridium botulinum.¹ Officials in two states have collected leftover formula from the implicated households, and laboratory results are expected in the coming weeks.² The three product lots consumed by the affected infants—identified as 709125280E14F2, 709125288E14F2, and 708125174E14F2—have been identified, though the full recall encompasses all lots currently in market.¹

The formula was distributed nationally through Target retail stores, Target.com, and Nara.com between July 2025 and June 2026. The product is manufactured in Europe and is not distributed outside the United States. Nara Organics represents less than 1% of all infant formula sold in the country, and shortage concerns are not anticipated.²

Clinical presentation of infant botulism and diagnostic approach

Infant botulism occurs when ingested C. botulinum spores colonize the large intestine and elaborate botulinum neurotoxin, producing a descending, flaccid paralysis.³ The disease typically begins with constipation, present in approximately 90% of cases at onset, followed by poor feeding, loss of head control, diminished facial expression, and difficulty swallowing.⁴ Without treatment, the illness can progress to respiratory failure requiring prolonged mechanical ventilation and weeks of hospitalization.³

Critically, diagnosis is based on clinical presentation. Treatment with BabyBIG should be initiated as soon as clinical consultation supports the diagnosis and should not be delayed pending laboratory confirmation.² The CDPH IBTPP, the world's sole producer of BabyBIG, provides 24/7 case consultation at 510-231-7600.

Clinicians should be alert to the extended incubation window: symptoms of infant botulism can take several weeks to develop following ingestion of contaminated formula.² This delay may complicate clinical attribution, particularly as awareness of the recall builds in the weeks ahead. Parents of infants who consumed Nara Organics formula are advised to monitor for symptoms for at least one month after the last feeding.⁶

Regulatory and testing gaps: powdered infant formula and spore-forming pathogens

This outbreak unfolds against the backdrop of a larger, unresolved regulatory question about the safety testing of powdered infant formula. Unlike ready-to-feed formula, powdered infant formula is not considered a sterile product.⁴ The FDA currently mandates testing finished formula for Cronobacter and Salmonella, neither of which forms spores, but does not require testing for spore-forming pathogens such as C. botulinum.⁴

C. botulinum spores are heat-resistant and can survive standard manufacturing processes. They are commonly found in the environment, including soil, dust, and some vegetables, and can enter facilities via contaminated surfaces or ingredients.⁵ The preceding ByHeart outbreak, which resulted in approximately 48 confirmed or suspected cases across 17 states before being declared over in February 2026, prompted the FDA and international food safety bodies to initiate a formal risk assessment of spore-forming organisms in powdered infant formula.⁵ That assessment remains ongoing.

Implications for clinical practice and outstanding investigation questions

The second powdered formula-linked botulism outbreak in under a year underscores the importance of clinician vigilance for the disease in formula-fed infants, particularly those presenting with constipation, hypotonia, or feeding difficulty, even when the connection to a recalled product is not immediately apparent.

Cases of infant botulism typically occur sporadically, and formula-associated outbreaks are historically rare.³ The emergence of a second outbreak before a root-cause determination in the first raises questions that the FDA's ongoing investigation will need to address: whether shared ingredient sourcing, manufacturing vulnerabilities, or environmental contamination pathways are implicated, and whether expanded finished-product testing requirements are warranted.

Physicians suspecting infant botulism should not await laboratory results before initiating treatment and should contact state health departments to report cases, as infant botulism is a nationally notifiable disease.²

References

1. Nara Organics. Nara Organics recalls all lots of Nara Infant Formula because of possible health risk. US Food and Drug Administration. June 13, 2026. June 15, 2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk

2. US Food and Drug Administration. Outbreak investigation of infant botulism: powdered infant formula (June 2026). Updated June 13, 2026. June 15, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026

3. Lavery AM, Chatham-Stephens K, Gierke R, et al. Multistate infant botulism outbreak associated with powdered infant formula. NEJM Evidence. 2026. doi:10.1056/EVIDpha2600020

4. Centers for Disease Control and Prevention. Infant botulism outbreak linked to powdered infant formula, June 2026. Updated June 14, 2026. Accessed June 15, 2026. https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/index.html

5. US Food and Drug Administration. Post-outbreak response activities: Clostridium botulinum illnesses associated with consumption of powdered infant formula. Updated June 2026. June 15, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/post-outbreak-response-activities-clostridium-botulinum-illnesses-associated-consumption-powdered