Nara Organics Baby Formula Lawsuit Claims Infant Botulism Infection Required Hospitalization

Federal health officials began investigating Nara Organics infant formula in June after three children in California, Pennsylvania and Washington developed confirmed or suspected cases of botulism that required hospitalization.

A California woman has filed a lawsuit on behalf of her infant son, alleging that he developed botulism and required hospitalization after consuming contaminated Nara Organics infant formula.

The complaint (PDF) was brought by Stephanie Roltsch, on behalf of her child Preston Roltsch, in California Superior Court on June 17, naming Nara Organics Inc. and Target Corporation as defendants. The case was removed to the U.S. District Court for the Central District of California on August 11.

Roltsch claims Nara Organics and Target manufactured, distributed and sold an unreasonably dangerous product without adequate testing or warnings.

Nara Organics Recall

Infant botulism is a rare but extremely serious illness. It occurs when Clostridium botulinum spores grow in an infant’s large intestine and produce toxins that attack the nervous system. Symptoms may take several weeks to appear and can include constipation, difficulty swallowing, weak cries, poor head control, loss of appetite and drooping eyelids.

Without medical treatment, infant botulism may cause paralysis and could require weeks of hospitalization. In some cases, it can result in breathing difficulties, respiratory failure and even death.

Federal health officials began investigating a multistate outbreak of infant botulism linked to Nara Organics Whole Milk Organic Powdered Infant Formula in June 2026. At the time, there were three confirmed or suspected infant botulism illnesses in California, Pennsylvania and Washington. All three infants were hospitalized, but no deaths were reported.

At the urging of the U.S. Food and Drug Administration (FDA), Nara Organics issued a voluntary recall for the affected formula on June 13. Both the FDA and the U.S. Centers for Disease Control and Prevention (CDC) advised parents not to use any of the affected Nara Organics infant formula.

Following the recall, a lawsuit was filed against Nara Organics last month, alleging a Pennsylvania infant was hospitalized with botulism after drinking tainted Nara Organics infant formula. The infant suffered loss of head control, difficult swallowing and other side effects before being hospitalized.

Nara Organics Infant Formula Allegations

In the complaint, Roltsch indicates she purchased Nara Organics Whole Milk Organic Powdered Infant Formula from Target in March and April, which she fed to her son, Preston, on a daily basis.

On May 17, Preston began experiencing discomfort, loss of appetite, weakness, hoarse crying and constipation. Roltsch took him to Southwest Healthcare Rancho Springs Hospital, where doctors determined that he required specialized care and transferred him to Kaiser Permanente Fontana Medical Center. He remained hospitalized there until May 28.

While hospitalized, Preston received BabyBIG, the FDA recommended treatment for infant botulism. According to the complaint, he continues to require ongoing medical care.

The lawsuit alleges the Nara Organics formula was defective and posed a danger to infants. It argues the company should have known of the potential contamination, and acted negligently by failing to warn consumers.

Roltsch also alleges that Nara Organics failed to maintain sanitary conditions during the manufacturing and distribution process and did not take adequate precautions to prevent the formula from being exposed to human or animal fecal contamination, which can introduce C. botulinum spores.

“Defendants failed to give adequate warnings of the product’s dangers that were known or by the application of reasonably developed human skill and foresight should have been known. Defendants also failed to give adequate warnings and instructions to avoid such dangers. Defendants’ failure to provide such warnings and instructions rendered the product unreasonably dangerous.”

— Stephanie Roltsch v. Nara Organics Inc. et al.

The lawsuit raises allegations of strict products liability, negligence and breach of implied warranty. It seeks compensation for pain and suffering, mental anguish, physical impairment, loss of enjoyment of life, past and future medical and pharmaceutical expenses, travel and travel-related expenses, emotional distress, lost wages, lost earning capacity and attorney’s fees.

ByHeart Infant Formula Lawsuits

Roltsch’s claim comes amid growing concerns about infant botulism involving powdered formulas. Last year, ByHeart recalled two batches of infant formula linked to a nationwide botulism outbreak that sickened at least 48 children.

A number of families have since filed ByHeart formula recall lawsuits, alleging contaminated formula caused their children to develop infant botulism.

Those cases have been consolidated in a ByHeart formula infant botulism MDL before the Southern District of New York, where U.S. District Judge Denise L. Cote is overseeing coordinated discovery and pretrial proceedings.

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