FDA Recalled Nara Organics Formula After 3-State Botulism Outbreak
The FDA announced a voluntary recall of Nara Organics Whole Milk Organic Powdered Infant Formula on June 14, 2026, after three infants were hospitalized with botulism. The babies, all between 2 and 5 months old, became ill in April and May in California, Pennsylvania, and Washington after consuming the formula.
3 infants hospitalized across 3 states in a multistate infant botulism outbreak tied to Nara Organics formula, per the FDA.
All three infants were treated with BabyBIG, the only FDA-approved treatment for infant botulism. BabyBIG is an IV medication derived from the blood plasma of people immunized against botulism toxin, and it is the sole available intervention once symptoms develop.
What Infant Botulism Does to Babies Under Age 1
Infant botulism is a rare but serious illness that affects babies under one year old, whose gut microbiomes are not yet mature enough to block botulism spores. When infants consume food contaminated with spore-producing bacteria, the bacteria release a toxin inside the gut.
Symptoms to watch for include constipation, weak muscle tone, drooping eyelids, poor feeding, difficulty swallowing, and breathing problems. Any baby showing these symptoms after consuming this formula needs immediate emergency care.
The Formula Was Sold at Target and Nara.com Nationwide
Nara Organics Whole Milk Organic Powdered Infant Formula was sold at Target stores across the United States and directly through Nara.com. The formula is manufactured in Europe but distributed exclusively in the U.S. market. Nara Organics accounts for less than 1% of all infant formula sold in the United States, so the FDA says the recall does not create a shortage risk.
The CDC advises anyone with an opened can to photograph the label, record the lot number and use-by date, and label the container “DO NOT USE.”
“Label it ‘DO NOT USE’ and keep it stored in a safe place away from other items you feed your baby for at least a month. If no symptoms appear after a month, throw the leftover formula away.”
U.S. Centers for Disease Control and Prevention, June 14, 2026
This recall follows a previous infant botulism case involving ByHeart baby formula, in which two companies that supplied dried milk powder were linked to contamination. That case raised questions about ingredient sourcing and supplier oversight in the infant formula supply chain that the FDA has not yet fully resolved.
What You Can Do Now
-
Check the FDA’s recall database at fda.gov/safety/recalls-market-withdrawals-safety-alerts to verify whether your can’s lot number and use-by date are included in the recall. Do not wait for symptoms to appear before stopping use of the formula.
-
Report any illness to the FDA’s MedWatch program at fda.gov/safety/medwatch or by calling 1-800-332-1088. Tell them the child’s age, the lot number from the formula can, and the symptoms observed. Reports from caregivers help the FDA identify the scope of contamination and issue additional alerts.
-
Call your congressional representative at (202) 224-3121 and ask them to support increased FDA inspection authority over foreign-manufactured infant formula ingredients. Nara Organics formula is produced in Europe; current FDA protocols for overseas supplier audits are voluntary and infrequent.
-
Contact your pediatrician today if your infant consumed this formula in the past 60 days, even without visible symptoms. Botulism symptoms can present gradually and may be mistaken for other conditions. Name the product and lot number when you call.
Update, July 3, 2026: A lawsuit was filed against Nara Organics in late June on behalf of an infant who allegedly contracted botulism from the company’s formula. Investigative journalists at Food Safety Magazine identified Organic West as the shared whole milk powder supplier for both Nara Organics and ByHeart, whose formula was recalled in November 2025 following an outbreak linked to 48 hospitalizations across 17 states.
The FDA inspected Nara Organics’ German manufacturing facility in May 2026 and found deficiencies; the company submitted corrective actions that remain under agency review. A June advisory from the California Department of Public Health linked three infant botulism cases from late April and May directly to Nara Organics formula. The FDA said there is insufficient evidence to conclude whole milk powder was the source of contamination and that the root cause investigation remains ongoing.
The FDA lost approximately 3,100 employees under the Trump administration’s reorganization, according to then-commissioner Martin Makary’s congressional testimony in May 2026. Steven Mandernach, executive director of the Association of Food and Drug Officials, told Congress in April that states conducted nearly 2,000 recall checks within the first week of the ByHeart response, while the FDA conducted only 21. Sarah Mayne, former director of the FDA’s Center for Food Safety and Applied Nutrition and now a professor of public health at Yale, said the agency is “especially lacking infant formula investigators.”
Sources
PBS NewsHour/AP: Nara Organics Recalls Baby Formula After Multistate Infant Botulism Outbreak FDA: Infant Botulism Information and BabyBIG Treatment Overview CDC: Infant Botulism Symptoms, Causes, and Prevention FDA: Safety Recalls, Market Withdrawals, and Safety Alerts Database PBS NewsHour/AP: Two Companies Supplied Dried Milk Powder Linked to Botulism in ByHeart Formula