Three infants in California, Pennsylvania, and Washington have been hospitalized with confirmed botulism after consuming Nara Organics Whole Milk Organic Powdered Infant Formula — prompting a nationwide recall that federal health officials say every parent who purchased this formula must act on immediately.
The FDA and CDC issued a joint alert on June 13, 2026, after the California Department of Public Health's Infant Botulism Treatment and Prevention Program (IBTPP) — the world's only producer of the infant botulism antitoxin BabyBIG — identified three type A toxin infections in infants who had all consumed Nara formula. No deaths have been reported, but all three infants required hospitalization and treatment with BabyBIG, the only approved therapy for the condition.
What Parents Must Do Right Now
If your household has any Nara Organics Whole Milk Organic Powdered Infant Formula, stop using it immediately. The recall applies to all lot numbers and both container sizes — the 400g and 700g cans. The formula was sold at Target retail stores, Target.com, and Nara.com between July 2025 and June 2026.
The three specific lot numbers tied to the sickened infants are 709125280E14F2, 709125288E14F2, and 708125174E14F2, found on the bottom of the can. However, the FDA states that all lots are included in the voluntary recall — meaning parents should not consider any Nara product safe for use, regardless of lot number.
The CDC advises that symptoms of infant botulism can take several weeks to develop. Parents whose infants consumed Nara formula should monitor their child for symptoms for a full month after the last use. Surfaces and items that touched the recalled formula should be washed with hot soapy water or run through a dishwasher.
| Data Point | Detail |
| Total confirmed cases | 3 |
| States affected | California, Pennsylvania, Washington |
| Infants hospitalized | 3 |
| Deaths reported | 0 |
| Illness onset range | April–May 2026 |
| Last illness onset | May 31, 2026 |
| Recall announced | June 13, 2026 |
| Products recalled | All lots, 400g and 700g Nara Organics Whole Milk Organic Powdered Infant Formula |
| Distribution | Target stores, Target.com, Nara.com (July 2025–June 2026) |
| Antitoxin used | BabyBIG (Botulism Immune Globulin Intravenous) |
A Recurring Problem That Demands Answers
This outbreak is the second infant botulism recall tied to powdered formula in less than a year. In mid-2025, ByHeart infant formula was recalled after approximately 48 illnesses, including 28 confirmed cases, were linked to Clostridium botulinum contamination. That recall raised questions about the adequacy of federal testing standards — and those questions have not been fully resolved.
Currently, the FDA requires formula manufacturers to test finished products for Cronobacter and Salmonella species — but not for C. botulinum spores. According to Consumer Reports, advocates and safety experts have pushed the FDA to expand its mandatory testing requirements to include spore-forming pathogens like C. botulinum following the ByHeart outbreak. That expansion has not yet taken effect — and a second botulism-linked formula recall in under a year raises the question of whether voluntary recalls triggered by illness reports are sufficient, or whether pre-market testing standards need to be strengthened.
Nara Organics is a Europe-based manufacturer whose formula accounted for less than 1% of the U.S. infant formula market, meaning no widespread shortages are expected as a result of this recall. In a statement released through the FDA recall notice, the company said: "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."
It is important to note that as of the recall announcement, no Nara formula lots had tested positive for C. botulinum. The recall is voluntary and precautionary, based on the epidemiological link between the product and confirmed illnesses. The FDA's investigation is ongoing, and product testing results are expected in the coming weeks.
Who Is Most at Risk — and What Symptoms to Watch
Infant botulism occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract of very young infants, producing toxins that attack the nervous system. It is a disease of age: the immature gut of infants under one year old is uniquely vulnerable to spore colonization. Older children and adults are not at risk from consuming the same spores.
The three infants in this outbreak were between 2 and 5 months of age at the time of illness onset. Parents should watch for these warning signs, which can appear gradually over days or weeks:
- Constipation (often the first symptom)
- Difficulty sucking or swallowing
- Weak or altered cry
- Poor head control or generalized weakness
- Drooping eyelids or sluggish pupil response
- Facial weakness
- Breathing difficulty — the most serious sign
The CDC warns that without treatment, infant botulism can cause progressive paralysis leading to respiratory failure, potentially requiring weeks of intensive hospital care. If any of these symptoms appear in an infant who consumed Nara formula, parents should seek emergency medical care immediately — before using the FDA's online Safety Reporting Portal.
Medical Context: What Is Infant Botulism?
Botulism is caused by neurotoxins produced by the bacterium Clostridium botulinum. The infant form differs from foodborne botulism in adults: rather than ingesting preformed toxin, infants ingest spores that then germinate and produce toxin inside the gut. The spores are naturally present in soil, dust, and some plant products — making their complete elimination from all powdered food products a technical challenge.
Powdered infant formula is not a sterile product, unlike ready-to-feed liquid formula. This distinction matters: C. botulinum spores can survive standard manufacturing processes that eliminate many other pathogens. Treatment with BabyBIG, produced exclusively by the California Department of Public Health, can neutralize circulating toxin and significantly reduce the duration and severity of illness when administered early. The sooner treatment begins, the better the outcome.
Frequently Asked Questions
What happened with the Nara Organics recall?
Three infants across California, Pennsylvania, and Washington were hospitalized with confirmed botulism between April and May 2026. The CDC and FDA linked all three cases to Nara Organics Whole Milk Organic Powdered Infant Formula, sold at Target stores, Target.com, and Nara.com. Nara Organics voluntarily recalled all lots on June 13, 2026.
Which lot numbers are affected?
All lots of Nara Organics Whole Milk Organic Powdered Infant Formula are recalled, regardless of lot number. The three lots directly linked to sick infants are 709125280E14F2, 709125288E14F2, and 708125174E14F2.
What symptoms should parents watch for?
Constipation, weak cry, difficulty feeding, poor muscle tone, drooping eyelids, and breathing difficulty. Symptoms can appear up to a month after the last consumption. Seek emergency care immediately if these signs develop.
Is it safe to buy other brands of infant formula right now?
Yes. The Nara Organics recall is limited to that brand only. It accounts for less than 1% of U.S. formula sales, and no formula shortage is expected. Parents who used other brands do not need to take any action related to this recall.
What is the FDA doing?
The FDA contacted Nara Organics on June 12, 2026, and recommended a recall. Testing of remaining formula samples from two states is underway, with results expected in the coming weeks. The FDA's outbreak investigation is ongoing, and updates will be published at FDA.gov.
