Organic Baby Formula Recalled Nationwide After Three Infants Hospitalized with Botulism

Voluntary Recall Issued Following Multistate Outbreak

Nara Organics has issued a voluntary recall of its organic baby formula after three infants who consumed the product were hospitalized with infant botulism. The Food and Drug Administration announced the recall on Saturday, affecting products sold at Target stores throughout the United States and online at Target.com and Nara.com. The sickened babies, ranging in age from 2 to 5 months, were located in California, Washington, and Pennsylvania. Federal authorities confirmed all three babies became ill in April and May and received treatment at hospitals.

The Centers for Disease Control and Prevention confirmed that all three babies had consumed Nara Organics Powdered Infant Formula before developing symptoms. All three babies were successfully treated with the FDA-approved medication for infant botulism, and no deaths have been reported, according to the FDA notice. The formula is manufactured in Europe but sold exclusively in the United States, according to the CDC statement.

The company has taken aggressive action to address the situation. No lots of Nara Organics Powdered Infant Formula have tested positive for Clostridium botulinum, the bacteria that causes infant botulism, according to the FDA. Despite this, the company voluntarily recalled all whole milk infant powdered formula products as a precautionary measure. The three product lots consumed by the sickened babies are 709125280E14F2, 709125288E14F2, and 708125174E14F2, according to the FDA.

Company Response and Safety Measures

“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,” the company said in the FDA notice.

Consumers should stop using the affected products immediately, according to the notice. The lot numbers can be found on the bottom of the formula cans, allowing parents and caregivers to quickly identify whether their product is part of the recall. The FDA emphasized the importance of immediate action to protect infant health and prevent additional cases.

Nara Organics Whole Milk Organic Infant Formula makes up less than 1% of all infant formula sold in the United States. The outbreak does not create shortage concerns for parents and caregivers, the FDA said. This limited market share means alternative formulas remain widely available for families affected by the recall.

Refund Process for Affected Customers

The company has established a comprehensive refund program for customers who purchased the recalled formula. Anyone who purchased formula from Nara.com between May and June 2026 will receive an automatic refund without needing to take additional action. Other customers who bought the product from Nara.com can request a refund online through the company’s website.

Consumers who purchased the product at Target stores should return the product there or visit Target’s website for a refund. The retailer has implemented procedures to process returns efficiently and ensure affected customers receive their money back promptly. Parents should not wait to return the product, even if their infant has not shown symptoms.

Understanding Infant Botulism and Its Symptoms

Infant botulism is a rare but serious illness that occurs in babies under age 1, whose gut microbiomes are immature. It occurs when Clostridium botulinum spores enter and colonize the intestinal tract. The spores then produce botulinum neurotoxins that grow in the gut, causing the illness, according to the CDC.

Affected babies may show multiple warning signs that require immediate medical attention. Symptoms include constipation, poor feeding, drooping eyelids, and sluggish pupils. Additional indicators involve low muscle tone, difficulty sucking and swallowing, weak or altered crying, and difficulty breathing. Parents may also notice generalized weakness in their infant. Respiratory arrest is possible, and the disease can be fatal without proper treatment.

CDC Recommendations for Formula Handling

The CDC issued specific guidance for families who have the recalled formula in their homes. People who have the formula should stop using it immediately, the CDC said in a statement. Parents should take a picture of any opened can and record the lot number and use-by date for documentation purposes. Vigilant monitoring of infants for symptoms is essential during the following weeks.

The CDC recommended marking any recalled formula containers clearly. Parents should label the can to indicate it should not be used and store it in a safe location away from other baby feeding items for at least one month. This storage period allows time for symptoms to appear if an infant was exposed. If no symptoms appear after a month, families can throw the leftover formula away safely.

Treatment and Medical Response

Babies who develop botulism symptoms need immediate medical attention. The sole treatment is BabyBIG, an IV medication made from blood plasma of people immunized against botulism. The FDA has approved this treatment specifically for infant botulism cases. Early intervention significantly improves outcomes, which is why recognizing symptoms quickly is critical for parents and caregivers.

The three hospitalized infants in this outbreak received BabyBIG treatment and recovered successfully. Federal health officials continue to investigate the root causes of these cases to prevent future incidents. The collaborative effort between the FDA, CDC, and state partners demonstrates the comprehensive approach to protecting infant health and maintaining formula safety standards across the nation.