Nara Organics Formula Lawsuit Filed Over Ongoing Infant Botulism Outbreak

FDA is currently testing samples to confirm presence of Clostridium botulinum bacteria and expects the results within the coming weeks.

A Pennsylvania couple has filed a lawsuit alleging their infant was hospitalized with botulism after drinking tainted Nara Organics infant formula, which has been linked to several similar illnesses.

The complaint (PDF) was brought by Erica and Micky Goldfin, on behalf of their child W.G., in the U.S. District Court of Pennsylvania on June 22. It names Nara Organics Inc., Target Corporation and multiple John Does as whole powdered milk suppliers and/or manufacturers as defendants.

The Goldfins allege Nara Organics and Target should have known of the potential for the whole milk infant formula to become tainted with Clostridium botulinum toxin and should have taken better steps to prevent putting infants at risk.

Infant Botulism Outbreak

In June, the U.S. Centers for Disease Control and Prevention (CDC) announced an investigation into a botulism outbreak linked to Nara Organics whole milk infant formula. The multistate outbreak involves four cases, three of which led to infants being hospitalized. Confirmed infections have occurred in California, Pennsylvania and Washington beginning in April 2026, with the most recent case reported May 31.

Infant botulism is a rare illness linked to products tainted with spores of Clostridium botulinum bacteria. It naturally occurs in the soil and can enter food-manufacturing facilities and homes. However, it can form protective spores allowing it to survive pasteurization for long periods.

When C. botulinum is ingested, the spores can germinate in a child’s immature gastrointestinal tract and produce a neurotoxin. The illness is life threatening and among the many symptoms and side effects, it can cause paralysis, respiratory failure and death.

The CDC is currently investigating the outbreak with the U.S. Food and Drug Administration (FDA) the California Department of Health and the Infant Botulism Treatment and Prevention Program (IBTPP). They have confirmed all four infants were fed Nara Organic Whole Milk Powdered Infant Formula.

Federal health officials are currently testing samples from the lots to confirm the presence of the bacterial contamination.

The outbreak comes after another batch of infant botulism cases were linked to ByHeart infant formula in late 2025. That outbreak infected more than 50 children across 17 states and resulted in a ByHeart formula recall. The injuries and resulting recall prompted a series of ByHeart infant formula lawsuits similar to what the Goldfins have filed against Nara, indicating manufacturers failed to ensure their products were safe for infants.

Nara Organics Botulism Allegations

In their lawsuit, the Goldfins allege Nara Organics is the source of the botulism infection that hospitalized their infant, W.G., and that Nara knew, or should have known, about the potential for the infant formula to become tainted.

In 2023, the U.S. Food and Drug Administration (FDA) issued a warning to manufacturers that infant formula can easily become tainted with spores of C. Botulinum, and by late 2025 the ByHeart illnesses occurred, alerting authorities and the industry of the potential for outbreaks.

The complaint argues that Nara had a duty to exercise reasonable care when manufacturing the formula. However, Nara allegedly did not test the finished formula for the presence of the bacteria and only screened batches for sulphate-reducing clostridia.

The filing claims that W.G., who was born in early March, began eating the formula purchased from Target around March 5. Nearly two months later, the infant began exhibiting symptoms of botulism, including constipation, poor feeding, loss of head control and difficulty swallowing.

On June 1, W.G. was admitted to the Children’s Hospital of Philadelphia. He was treated in the intensive care unit for two nights, then treated in the general pediatric unit until June 6. As a result of the illness, W.G. requires continued physical therapy due to poor ability to lift the head and issues with gross and fine motor skills.

Nara allegedly marketed its infant formula as having received a special FDA designation allowing it to contain an elevated level of milk fat, purportedly higher than any other infant formula sold in the United States. However, the complaint argues that claim is misleading because the FDA does not approve infant formulas or conduct premarket approval before they are sold.

According to the lawsuit, the advertising falsely suggested the product had received a unique FDA endorsement, which was intended to reassure parents and influence them to buy a formula the plaintiffs claim was dangerous.

“By the time Nara manufactured, imported, distributed, marketed, and sold the Formula—and certainly during the outbreak’s April through May 2026 illness-onset window and Nara’s July 2025 through June 2026 distribution window—the powdered-infant-formula industry generally, and Nara in particular, knew or in the exercise of reasonable care should have known that whole milk powder used to manufacture powdered infant formula could harbor C. botulinum and cause infant botulism.”

— Erica and Micky Goldfin v. Nara Organics Inc. et al.

The complaint presents claims of strict product liability, breach of express and implied warranties, negligence, negligence per se and punitive damages. The Goldfins are seeking compensation for past and future medical attention, pain and suffering, past and future loss of enjoyment of life, past and future physical impairment and disability, mental anguish, emotional distress and disfigurement.

Nara Organics Recall

At the recommendation of the FDA, the manufacturer agreed to issue a Nara Organics infant formula recall on June 13. The recall includes Nara Organics Whole Milk Infant Formula, 700g, with UPC 860013251901 and Nara Organics Whole Milk Infant Formula, 400g, with UPC 860013251918.

The tainted Nara Organics formula was distributed nationally via Target retail stores and online, as well as Nara.com from July 2025 to June 2026. The formula is manufactured in Germany, but was not sold outside of the U.S.

Consumers are urged to stop using the affected products immediately. If they have fed the recalled products to their infants, they should contact their healthcare provider for immediate care should their children present symptoms of:

• Vomiting
• Diarrhea
• Constipation
• Poor feeding
• Drooping eyelids
• Weak crying

Nara indicates it will automatically refund any purchases made of the affected products through its website in May and June 2026. Other customers with affected products can take a photo of the bottom of each can and fill out a refund form or follow Target’s in-store and online return instructions.

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