Nara Organics Recalls Baby Formula After Botulism Outbreak

Nara Organics has recalled all lots of its Whole Milk Organic Powdered Infant Formula after a multistate outbreak of infant botulism sickened three babies across California, Pennsylvania, and Washington, federal health officials announced. The infants — aged 2 to 5 months — became ill between April and May 2026 after consuming the formula, which was sold at Target stores nationwide, Target.com, and Nara.com. All three were hospitalized and treated with BabyBIG®, the FDA-approved antitoxin, according to the Associated Press. No deaths have been reported.

What Happened

The U.S. Food and Drug Administration contacted Nara Organics on June 12, 2026, recommending a recall due to the severity of illness and the epidemiological signal. The following day, the Europe-based manufacturer agreed to recall all lots of its Whole Milk Organic Powdered Infant Formula — covering both the 700g (UPC 860013251901) and 400g (UPC 860013251918) sizes. The formula had been distributed nationally from July 2025 through June 2026.

The Centers for Disease Control and Prevention issued a food safety alert urging parents and caregivers to immediately stop using the recalled formula. The CDC advised that anyone with an opened can should label it “DO NOT USE,” store it safely away from other food for at least a month, and monitor their infant for symptoms. If no symptoms appear after a month, the formula should be discarded.

Understanding Infant Botulism

Infant botulism is a rare but serious illness that occurs when infants consume spores of Clostridium botulinum bacteria. Unlike adult botulism, which results from ingesting pre-formed toxin, infant botulism happens when spores germinate in the immature gut microbiome and produce toxin inside the body. Symptoms include constipation, poor feeding, drooping eyelids, weak muscle tone, difficulty swallowing, and breathing problems. The sole treatment is BabyBIG®, an intravenous medication made from blood plasma of immunized donors.

According to the CDC, symptoms can take several weeks to appear, and clinicians should begin treatment as soon as infant botulism is suspected — without waiting for laboratory confirmation.

A Troubling Pattern

This outbreak marks the second infant formula-linked botulism outbreak in the United States in less than seven months. In November 2025, the ByHeart Whole Nutrition Infant Formula outbreak sickened 48 infants across 17 states. Whole genome sequencing tied that outbreak to Clostridium botulinum in organic whole milk powder — the same ingredient implicated in the current Nara Organics recall, as reported by NBC News.

Seattle food safety attorney Bill Marler, who represents more than 20 families from the ByHeart outbreak, offered sharp criticism of the recurring pattern. “For the second time in seven months, parents are being told that the powdered formula they trusted to feed their baby may carry the toxin that causes botulism — and once again, the implicated ingredient is whole milk powder, and once again the product was on the shelves at Target,” Marler told Food Safety News. “Three babies are in the hospital. Mercifully, no one has died. But a recall after the fact is not a food safety system — it is a bad apology.”

Marler noted that the FDA issued guidance to the infant formula industry in March 2023 specifically naming Clostridium botulinum as a hazard that manufacturers must control in powdered infant formula. He also highlighted that after the ByHeart outbreak, the FDA had to send warning letters to Target, Walmart, Kroger, and Albertsons because recalled formula remained on store shelves — in some cases restocked and discounted — weeks after the recall began.

Market Impact and Investigation

Nara Organics represents less than 1% of all infant formula sold in the United States, and the FDA has stated that the outbreak does not create shortage concerns for parents and caregivers. Officials in two states have collected leftover infant formula for testing, with results expected in the coming weeks. The FDA’s investigation remains ongoing.

What to Watch For

As testing results become available in the coming weeks, several critical questions remain unanswered: whether the contamination is linked to the whole milk powder ingredient as in the ByHeart outbreak, whether additional cases will be identified as surveillance intensifies, and what regulatory changes — if any — the FDA will implement to prevent a third outbreak. For now, health officials urge any parent who has purchased Nara Organics formula to stop using it immediately and consult a doctor if their infant shows any signs of illness.