June 23, 2026
Provided Image/FDA
A Bucks County couple has filed a lawsuit against formula company Nara Organics, product pictured above, after their child was one of three who consumed the formula and was later diagnosed with infant botulism.
A family in Yardley has filed a lawsuit against a formula company after their 2-month-old was one of three babies hospitalized in an infant botulism outbreak.
On June 15, Nara Organics announced a voluntary recall of its powdered formulas after three cases of botulism were found in California, Pennsylvania and Washington. The illnesses began in April and the most recent was reported May 31, and all of the babies had consumed company's products.
Infant botulism can occur when babies consume spores of Clostridium botulinum, which then form a toxin in their blood stream. It can cause a slow-forming muscle paralysis and can be deadly if it spreads to the muscles used for breathing.
None of Nara's products have tested positive for Clostridium botulinum so far, but the company issued the recall as a precautionary measure. Public health officials are testing leftovers from the formula in two of the cases, and those results are expected in the coming weeks.
According to the lawsuit, which was filed Monday in federal court in Philadelphia, Erica and Micky Goldfin said their child, who was not identified, began showing symptoms of infant botulism in early May. They included poor feeding, weak cries and difficulty swallowing. The baby was admitted to the Children's Hospital of Philadelphia on June 1 and spent two nights in the intensive care unit before being discharged on June 6.
The Goldfins used Nara Organics formula starting a few days after the baby was born. They purchased the products from a Target, which was also named in the lawsuit, in Langhorne and through an online order with a pickup in Princeton, New Jersey.
The botulism contaminant is a spore-forming organism that can survive the pasteurization and drying process which turns milk into powder. However, the lawsuit says Nara did not test directly for the contaminant and instead screened for other microbiological parameters. Nara's website says it tests for 13 microorganism parameters, despite the fact that only two are FDA-mandated.
The document also states that Nara misled customers with claims about its FDA approval. Nara's marketing allegedly says it's the only USDA-certified organic infant formula made with whole milk and that it contains more milk fat than other formulas. According to the filing, the company claims to have received a special FDA designation for that higher level of milk fat, but the FDA does not issue premarket approvals for infant formulas.
"Those representations conveyed a false assurance that the Formula had received governmental safety vetting that it had not in fact received," the lawsuit says. "The representations were false or materially misleading, and Plaintiffs justifiably relied upon them in deciding to purchase the Formula and to feed it to (the baby)."
Nara's website says it held a clinical trial for its products, and the FDA had to review the results before the company could launch its formulas.
The lawsuit also noted that the outbreak involving Nara closely follows another similar outbreak with infant formula from ByHeart Whole Nutrition. From November 2025 through early 2026, 48 babies in 17 states became hospitalized with infant botulism cases linked to the formula before the Centers for Disease Control declared the outbreak over on Feb. 26. Health official first thought the illnesses began in August 2025, but later found some cases dating back to 2023.
Following that incident, the lawsuit argues that the company knew that it needed to exercise caution in its manufacturing, especially as it contained a higher percentage of whole milk fat. It also says that in March 2023, the FDA issued a call to action letter about the possible hazards of baby formulas, including infant botulism.
Nara Organics did not immediately return a request for comment on the lawsuit. Its recall page, which was last updated June 16, includes information about symptoms, receiving a refund and a link to its health and safety page for information about product testing. Nara said its products are inspected in accordance with both FDA and EU regulations, as well as Brand Reputation Compliance Global Standards certification.
"We believe in taking the strongest possible measure to protect the safety of babies," the company wrote. "That's why we quickly decided, in an abundance of caution, to voluntarily recall all Nara Organics infant formula currently available in the U.S. Your family deserves to have complete confidence in the safety of your baby's food."
