Abbott reaches agreement with Department of Justice to resolve claims relating to 2022 infant formula recall

Abbott has reached an agreement to resolve the previously disclosed investigation and lawsuit brought by the United States Department of Justice, as well as lawsuits filed by certain relators and the Attorneys General of several states, relating to Abbott's manufacturing and 2022 recall of powdered infant formula at its facility in Sturgis, Mich. Abbott will pay a total of $385 million to resolve the claims. The settlement does not represent any finding of fault or liability. Additionally, as the government has previously indicated, it has closed its criminal investigation regarding this matter. Importantly, no unopened, distributed Abbott infant formulas have ever tested positive for Cronobacter sakazakii . Consistent with this, the FDA confirmed in early March 2022 that the unopened product from the homes of the infants under investigation at the time of the 2022 recall tested negative for Cronobacter sakazakii. The CDC later concluded there was no definitive link between the Sturgis facility and the clinical cases under investigation at that time. Nothing matters more than the safety and quality of Abbott's products. We make infant formula with the same care we would for our own families and are deeply committed to earning and maintaining caregivers' trust. As we move forward, Abbott remains focused on serving the families who depend on us every day.

Cronobacter is a ubiquitous bacterium that is known to harbor in homes (especially kitchens), bottled water and unsanitized feeding equipment (like breast pumps), as well as all infant formula manufacturing facilities. A study published in July 2024 in the American Society for Microbiology's Applied and Environmental Microbiology journal showed that out of 263 households in the U.S., 36% had at least one environmental positive swab for Cronobacter spp. and 25% had Cronobacter sakazakii , confirming its ubiquity. And those findings were based on an average of just 10 swabs per house.

Yes, they were tested. No unopened, distributed Abbott infant formulas have ever tested positive for Cronobacter sakazakii or Salmonella Newport . Additionally: Abbott retains samples from all lots of all products distributed. Samples from the lots that corresponded to those that were consumed by the infants were tested. All tested negative. Genetic sequencing on the available samples from two of the ill infants did not match the strains of Cronobacter found in the plant. Nor did the available samples from the infants match one another, indicating that the two cases did not have a common source. That's important because microbiologists tell us that the DNA sequence is a critical element for determining origin. Institutions performing the testing of the other three infants did not retain or provide the clinical sample for Whole Genome Sequencing (WGS). The lack of this data is not a miss from Abbott Nutrition.

In all five cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all five cases, all unopened containers tested negative. Open containers from the homes of the infants were also tested in four of the five cases; three of the four t...