Abbott to Pay $385 Million to Settle DOJ Infant Formula Recall Claims

Abbott announced on September 14, 2026, that it has reached an agreement to pay $385 million to resolve a previously disclosed U.S. Department of Justice investigation and lawsuit, as well as lawsuits filed by certain relators and the Attorneys General of several states, relating to the company’s manufacturing and 2022 recall of powdered infant formula at its facility in Sturgis, Michigan.

The settlement does not represent any finding of fault or liability, Abbott said in the announcement, issued from Abbott Park, Illinois. The company also said the government has previously indicated that it has closed its criminal investigation regarding the matter.

According to the company, five complaints involving infant illnesses were ultimately the reason for the 2022 recall. In all five cases, state regulators, the FDA, and/or the CDC tested samples of the Abbott formula used by the child, and every unopened container tested negative for Cronobacter sakazakii. Open containers from the infants’ homes were tested in four of the five cases, and three of those four tested negative.

The one positive result came from an open container taken from an infant’s home, Abbott said. That container tested positive for two different strains of Cronobacter sakazakii, neither of which was found in the Sturgis plant. One strain matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula.

Abbott said the FDA confirmed in early March 2022 that unopened product from the homes of the infants under investigation at the time of the recall tested negative for Cronobacter sakazakii, and that the CDC later concluded there was no definitive link between the Sturgis facility and the clinical cases under investigation at that time. The company also said FDA testing of product batches and retained product samples collected from the Sturgis facility during the agency’s inspection were all negative for Cronobacter sakazakii and Salmonella, and that no unopened, distributed Abbott infant formulas have ever tested positive for Cronobacter sakazakii or Salmonella Newport.

Product Testing and Genetic Sequencing

Abbott said it retains samples from all lots of all products it distributes, and that samples from the lots corresponding to those consumed by the infants were tested, with all testing negative. Genetic sequencing on available samples from two of the ill infants did not match the Cronobacter strains found in the plant, and the available samples from the two infants did not match one another, which the company said indicates the two cases did not have a common source. The institutions that performed testing on the other three infants did not retain or provide the clinical samples for Whole Genome Sequencing, according to Abbott.

The company said it learned in March 2023, through a CDC report, that Cronobacter sakazakii was recovered from breast pump parts used in the home of one of the four infants the FDA was investigating in 2022.

CDC Statements and Household Cronobacter Findings

In a video posted by the National Academies and cited in the announcement, CDC scientist Dr. Julia Haston states that the cases did not meet the definition of an outbreak and that there was “no definitive link” between the Sturgis facility and the cases investigated. One of the four cases was linked to powdered infant formula that was likely contaminated in the home after the formula was opened, she states. Haston also states that the CDC’s investigation found five invasive Cronobacter infections unrelated to the Sturgis facility, that powdered infant formula investigations most often suggest that contamination with Cronobacter occurs in the home, and that most cases linked to infant formula are not associated with an outbreak.

Abbott describes Cronobacter as a ubiquitous bacterium known to harbor in homes, particularly kitchens, in bottled water, and on unsanitized feeding equipment such as breast pumps, as well as in all infant formula manufacturing facilities. The announcement cites a study published in July 2024 in the American Society for Microbiology’s Applied and Environmental Microbiology journal, which found that out of 263 U.S. households, 36% had at least one environmental positive swab for Cronobacter spp. and 25% had Cronobacter sakazakii. Those findings were based on an average of 10 swabs per house, Abbott said.

The company said that following its 2022 recall, multiple infant formula manufacturers reported Cronobacter-related findings in manufacturing facilities and, in one instance, in finished, distributed product.

“Nothing matters more than the safety and quality of Abbott’s products,” the company said, adding that it makes infant formula with the same care it would for its own families and that it remains focused on serving the families who depend on it.