Key Takeaway:
- Nara Organics Recalls Infant Formula after three infants in California, Pennsylvania, and Washington developed botulism linked to its Whole Milk Organic Infant Formula products.
- All affected infants were hospitalized and treated; no deaths have been reported.
- FDA and CDC urge parents to stop using the recalled formula immediately and monitor infants for symptoms.
Nara Organics Recalls Infant Formula after federal health officials reported that three infants in California, Pennsylvania, and Washington developed botulism following consumption of its Whole Milk Organic Infant Formula, which had been sold nationwide.
CDC Links Three Infant Botulism Cases To Formula
Federal health officials announced the recall after three infants who consumed Nara Organics Whole Milk Organic Infant Formula between April and May were diagnosed with infant botulism, a rare but potentially life-threatening illness.
The Centers for Disease Control and Prevention said the infants, ages 2 to 5 months, became ill after consuming the formula. The cases were reported in California, Pennsylvania, and Washington.
All three infants were hospitalized and treated with BabyBIG, an antitoxin used to treat infant botulism. No deaths have been reported, according to the CDC.
“Infant botulism is a serious illness that can lead to progressive paralysis and breathing difficulties if left untreated,” the CDC said in a statement.
Nara Organics Recalls Infant Formula in a nationwide action covering all Whole Milk Organic Infant Formula products sold between July 2025 and June 2026 through Target stores, Target.com, and Nara.com.
FDA Urges Families To Stop Using the Recalled Product
The Food and Drug Administration advised parents and caregivers to immediately stop using the recalled formula and monitor infants for symptoms of botulism.
According to health officials, symptoms can take several weeks to appear and often begin with constipation. The illness may progress to difficulty sucking and swallowing, weak crying, poor head control, drooping eyelids, and facial weakness.
Without prompt treatment, botulism can cause severe muscle paralysis and respiratory failure, requiring prolonged hospitalization.
The FDA instructed consumers to keep any remaining product in a secure location away from other food items and clearly label it “Do Not Use.” State health officials may request samples for testing.
“If the infant has no symptoms and officials do not require the product for testing, consumers should discard or return the formula,” the agency said.
Officials Say Recall Unlikely To Affect Formula Supply
The FDA said Nara Organics, a Europe-based manufacturer, accounts for less than 1% of infant formula sales in the United States. Officials said the recall is not expected to disrupt the national infant formula supply.
The agency continues to investigate the source of contamination while working with state and federal health authorities.
Nara Organics Recalls Infant Formula following another infant botulism outbreak, which comes less than a year after ByHeart formula was linked to similar cases. In a June 2 update, the FDA reported that the ByHeart outbreak led to about 48 illnesses, including 28 confirmed cases, and triggered a nationwide recall.
Health officials said parents should seek immediate medical attention if infants who consumed the recalled formula show signs of botulism or other unusual symptoms.
Nara Organics has not reported any additional confirmed illnesses beyond the three cases identified by federal investigators.
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