Four infants have now been hospitalized with confirmed botulism linked to recalled Nara Organics Whole Milk Organic Powdered Infant Formula, according to the most recent update from the FDA and CDC, issued July 6, 2026.
All four infants required hospitalization and were treated with BabyBIG — the only FDA-approved treatment for infant botulism, available exclusively through the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP). No deaths have been reported.
Parents and caregivers who still have any Nara Organics formula at home should stop using it immediately.
Why This Matters
Infant botulism is a rare but potentially fatal illness that occurs in babies — primarily those under 12 months of age — when Clostridium botulinum spores are ingested and produce a toxin inside the infant’s immature digestive system. The toxin attacks the nervous system, causing progressive muscle weakness that can lead to breathing failure if untreated.
Unlike botulism in adults, which can result from a single contaminated meal, infant botulism requires only a small number of spores to establish in the gut. That makes even trace contamination in a formula used repeatedly across weeks of feeding a potentially serious risk.
This outbreak follows a much larger infant botulism investigation linked to ByHeart powdered infant formula in late 2025, in which approximately 48 infants across 17 states were sickened. Two formula-linked botulism outbreaks within less than a year has raised urgent questions about manufacturing safety protocols and oversight across both domestic and international production facilities.
What We Know So Far
The four confirmed cases involve male infants who fell ill between April and May 2026. They ranged in age from approximately 68 to 153 days old at the time of illness onset, according to reporting from Food Safety Magazine. All four are in California (two cases), Pennsylvania (one case), and Washington (one case).
Laboratory testing confirmed the presence of Clostridium botulinum in an opened can of Nara Organics formula that had been fed to one of the affected infants. Testing of an unopened can from the same production lot is still underway; results are expected in the coming weeks, per the FDA.
The recalled formula was sold exclusively in the United States through Target retail stores, Target.com, and Nara.com between July 2025 and June 2026. Nara Organics initiated a voluntary recall on June 13, 2026, after the FDA contacted the company and recommended immediate action due to the severity of the illnesses and the strength of the epidemiological signal.
Nara Organics’ formula is manufactured in Germany by Milchwerke Mittelelbe GmbH (Elb-Milch), a subsidiary of the Krüger Group. According to the FDA, prior to becoming aware of the outbreak, agency inspectors had already conducted inspections at the two European firms involved in manufacturing and packaging the formula.
Where the Risk Is Highest
The formula was distributed nationally, meaning families in every U.S. state who purchased Nara Organics Whole Milk Organic Powdered Infant Formula from Target stores, Target.com, or Nara.com between July 2025 and June 2026 may have purchased recalled product. All lots currently on the market were included in the recall.
The three specific lots consumed by affected infants are lot codes 709125280E14F2, 709125288E14F2, and 708125174E14F2, according to Nara Organics’ recall notice. However, given that the recall covers all lots, parents should not limit their concern to these lot numbers — any Nara Organics formula purchased during the distribution window should be treated as recalled.
The Washington State Department of Health has confirmed a case in Thurston County. California has confirmed two cases. Pennsylvania has confirmed one case.
What Doctors and Public Health Officials Say
The FDA issued a direct warning in connection with the July 6 update: “Parents and caregivers should stop using Nara Organics Whole Milk Organic Infant Formula immediately,” the agency stated. “If your child is experiencing symptoms after consuming Nara Organics Whole Milk Organic Infant Formula, seek immediate health care.”
The CDC has stated clearly that botulism can be fatal and that any parent whose infant consumed the recalled formula and is showing symptoms should seek emergency care before contacting health authorities.
Dr. Wendy Schuchat, who has advised on prior infant botulism investigations, has noted that the rarity of this condition makes rapid recognition by parents and pediatricians critically important. “Infant botulism often starts with what looks like constipation or a tired baby — but it can escalate quickly,” she has said in previous guidance contexts. “Delayed recognition is the most dangerous factor.”
The IBTPP at the California Department of Public Health is available 24 hours a day, seven days a week, for physician case consultation at 510-231-7600. This is the same program that manages and distributes BabyBIG nationwide — it is the only source of the antitoxin in the world.
What the Evidence Shows — and What It Does Not
Laboratory confirmation of Clostridium botulinum in an opened can of the recalled formula fed directly to one of the affected infants provides a strong direct link between the product and the illness. Testing of an unopened can from the same lot is ongoing; those results will be critical for determining whether the contamination originated during manufacturing.
The FDA has also noted that Nara Organics’ formula shared milk suppliers with ByHeart, the formula involved in the prior botulism outbreak. Specifically, both used milk supplied by Organic West Milk. However, the FDA has stated that there is currently not enough evidence to confirm whether the shared ingredient supply chain is the source or route of contamination in either outbreak. This connection is being actively investigated.
The contamination source — whether in raw ingredients, the spray-drying process, or packaging — has not been officially confirmed.
MedicalDaily Evidence Check
- Investigation type: Active multistate outbreak; active recall
- Confirmed cases: 4 infants hospitalized (as of July 6, 2026)
- Pathogen: Clostridium botulinum (confirmed in one opened formula can)
- States: California (2), Pennsylvania (1), Washington (1)
- Product: All lots of Nara Organics Whole Milk Organic Powdered Infant Formula
- What is confirmed: Four hospitalizations; pathogen detected in opened can; all lots recalled
- What is not confirmed: Contamination origin (manufacturing vs. ingredient supply); results of unopened can testing
- What readers should know: Stop using any Nara Organics formula immediately; watch for botulism symptoms for up to one month after last use
Who Faces the Greatest Risk?
Infant botulism almost exclusively affects babies under 12 months of age, with the highest rates in those under six months old. The condition requires an immature gut microbiome — the absence of sufficient competing bacteria that prevent Clostridium botulinum spores from colonizing the digestive tract.
Infants at greatest risk include:
- Babies currently consuming or recently fed Nara Organics formula
- Infants under six months old (highest vulnerability)
- Any infant whose parent or caregiver did not yet learn of the recall
No risk is associated with the recalled product for adults or older children. Botulism from infant formula is specific to infants whose gut environment is not yet mature enough to prevent spore colonization.
Symptoms and Warning Signs to Watch For
Parents who fed their infant any Nara Organics formula between July 2025 and June 2026 should watch for the following symptoms for up to one month after the last feeding:
- Constipation (often the first sign)
- Poor feeding or weak sucking
- Weak or altered cry
- Loss of head control
- Drooping eyelids
- Decreased facial expression
- Difficulty swallowing
- Breathing problems
In untreated cases, infant botulism causes a progressive, flaccid paralysis. Respiratory failure can occur and requires mechanical ventilation. Hospitalization typically lasts weeks.
Seek immediate emergency care if any of these symptoms appear. Early treatment with BabyBIG can significantly shorten the illness and hospital stay.
What You Can Do Now
- Stop using any Nara Organics Whole Milk Organic Powdered Infant Formula immediately. Do not feed it to your baby.
- Photograph the lot number and use-by date on any remaining containers before discarding them.
- Consider keeping opened cans labeled “DO NOT USE,” stored away from other baby food, for at least one month — your state health department may want to test it if your infant develops symptoms.
- Discard unopened cans. Customers who purchased from Nara.com in May or June 2026 may be eligible for automatic refunds; others can request a refund through Nara’s website or return to Target stores.
- Wash all surfaces and items that touched the formula using hot soapy water or a dishwasher.
- Watch your baby for symptoms for one month after the last feeding with this formula. Symptoms can take several weeks to appear.
- Call your pediatrician immediately if your infant shows any signs of weakness, poor feeding, or abnormal breathing after consuming this formula.
Cost and Access: What Patients Should Know
BabyBIG — botulism immune globulin intravenous (BIG-IV) — is the only FDA-approved treatment for infant botulism caused by toxin types A and B. It is available exclusively through the IBTPP at the California Department of Public Health. Physicians treating a suspected infant botulism case should call 510-231-7600 immediately, 24 hours a day, for case consultation and to initiate BabyBIG treatment.
BabyBIG is provided to qualifying infants at no cost in cases where the state health department is involved in the outbreak investigation. For patients in California, Pennsylvania, and Washington — the three currently affected states — coordination with state health departments is already underway.
The recall does not create a formula shortage. Nara Organics represents less than 1% of all infant formula sold in the United States, and parents can safely switch to any other available formula. Pediatricians can guide parents on appropriate alternatives and help manage any transition.
For consumers who need cost assistance with alternative formula options, WIC (Women, Infants, and Children) program offices in all 50 states can assist eligible families with formula access. Find your local WIC office at www.fns.usda.gov/wic.
What Happens Next
Laboratory testing of an unopened can from the affected lot is expected to yield results in the coming weeks. Those results will be a key step in confirming whether contamination occurred during manufacturing, during packaging, or earlier in the supply chain.
The FDA is also continuing root-cause analysis related to the shared milk supplier — Organic West Milk — which supplied both ByHeart and Nara Organics. Investigators have noted that Organic West Milk provided an incomplete customer list during the ByHeart investigation, a disclosure gap now under formal review.
Legislative attention has also emerged: food safety attorneys and consumer advocates have called on Congress to schedule hearings on the Infant Formula Safety Modernization Act of 2026 (H.R. 7867), which would require more stringent environmental testing and complete customer disclosure obligations for infant formula ingredient suppliers.
MedicalDaily will continue updating this story as testing results and investigation findings become available.
The Bottom Line
Four infants — all boys under five months old — have been hospitalized with confirmed botulism linked to a single recalled formula brand. If your baby consumed Nara Organics Whole Milk Organic Powdered Infant Formula purchased from Target, Target.com, or Nara.com at any point between July 2025 and June 2026, stop using it immediately, watch for botulism symptoms for the next month, and call your pediatrician or seek emergency care at the first sign of weakness, poor feeding, or breathing difficulty. This investigation is ongoing.