Nara Organics recalled its Whole Milk Organic Infant Formula sold nationwide after three children in three states developed infant botulism, according to federal health officials.
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The cases involve infants in California, Pennsylvania and Washington who consumed the formula between April and May, the Centers for Disease Control and Prevention said. The infants were between 2 and 5 months old when they became ill.
All three infants were hospitalized and treated with BabyBIG, an antitoxin used to treat infant botulism. According to the CDC, no deaths have been reported.
The recall covers all Nara Organics Whole Milk Organic Infant Formula products sold nationwide, including at Target stores, Target.com and Nara.com, between July 2025 and June 2026.
Infant botulism is a rare but serious illness that occurs when Clostridium botulinum spores grow in a baby’s large intestine and produce toxins that attack the nervous system.
Symptoms can take several weeks to appear and often begin with constipation. They can progress to difficulty sucking and swallowing, a weak or altered cry and poor head control. Infants may also experience drooping eyelids, sluggish pupils and facial weakness.
Without treatment, the illness can cause “progressive, flaccid paralysis that can lead to breathing difficulties, including respiratory failure, and require weeks of hospitalization,” the CDC said.
Parents and caregivers should immediately stop using the recalled formula.
The Food and Drug Administration advised consumers to keep any remaining product in a safe place away from other food and clearly mark it “Do Not Use,” as state health officials may request samples for testing. If the infant has no symptoms and officials do not need the product, it should be discarded or returned.
The FDA said Nara Organics, a Europe-based manufacturer, accounts for less than 1% of all infant formula sold in the United States and that the recall is not expected to affect the nation’s formula supply.
The recall comes less than a year after another infant botulism outbreak, linked to ByHeart formula, led to dozens of illnesses and a nationwide recall. In a June 2 update, the FDA said that outbreak resulted in about 48 illnesses, including 28 confirmed cases.