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Abbott has agreed to pay $385 million to resolve claims brought by the US Department of Justice, several whistleblowers and state Attorneys General relating to the company’s manufacturing and 2022 recall of powdered infant formula produced at its Sturgis, Michigan facility.

The settlement relates to the previously disclosed investigation and lawsuits concerning the facility, which manufactured Abbott infant formula before production was suspended and products were recalled in 2022 following reports of infant illnesses involving Cronobacter sakazakii.

Abbott said the agreement does not constitute an admission or finding of fault or liability. The company also confirmed that the US government has closed its criminal investigation into the matter.

The Sturgis facility became the focus of regulatory scrutiny after four infant illnesses were reported to the US Food and Drug Administration (FDA), alongside a fifth case subsequently considered as part of the investigation. The 2022 recall contributed to significant disruption in the US infant formula market, which was already experiencing supply pressures at the time.

According to Abbott, government testing found no Cronobacter sakazakii in unopened Abbott formula from the homes of the infants under investigation. The company also said that retained samples from the relevant production lots tested negative for both Cronobacter sakazakii and Salmonella Newport.

The company said testing of open containers from four of the five homes produced three negative results. One open container tested positive for two strains of Cronobacter sakazakii, neither of which was found at the Sturgis facility, according to Abbott.

Abbott also said genetic sequencing of available samples from two of the affected infants did not match strains identified at the Sturgis plant. The company said the clinical samples from those two infants also did not match one another.

The Centers for Disease Control and Prevention (CDC) subsequently concluded there was no definitive link between the Sturgis facility and the clinical cases investigated at the time.

CDC scientists have also said that the cases did not meet the definition of an outbreak and that investigations into powdered infant formula contamination most often point to contamination occurring in the home. In one of the cases associated with the 2022 investigation, Cronobacter was later recovered from breast pump equipment in the infant's home, according to Abbott.

Cronobacter is an environmental bacterium that can be found in a range of locations, including kitchens, feeding equipment and dry foods. The CDC notes that powdered infant formula can become contaminated with the bacteria, as can feeding items such as breast pump equipment.

The issue has continued to attract attention across the infant nutrition industry. Abbott said other formula manufacturers have subsequently reported Cronobacter-related findings at manufacturing facilities, while at least one manufacturer has faced a recall involving finished, distributed product.

For Abbott, the settlement brings a legal chapter stemming from the Sturgis investigation closer to a conclusion, although the company continues to emphasise the safety controls surrounding its infant formula production.

“Nothing matters more than the safety and quality of Abbott's products,” the company said, adding that it remains focused on maintaining the trust of parents and caregivers.

The $385m settlement resolves the claims covered by the agreement, while Abbott maintains that it has not been found liable in connection with the matter.