Abbott Agrees to $385 Million Settlement in 2022 Infant Formula Recall Case

News related to:Abbott · 1 min read

Abbott, a global healthcare leader, has reached an agreement with the United States Department of Justice to resolve claims related to the 2022 infant formula recall. The settlement, totaling $385 million, does not indicate any fault or liability on Abbott’s part.

According to the press release, the government has closed its criminal investigation into the matter. Regulators tested unopened infant formula from the homes of the infants under investigation at the time of the recall, and these tests were negative for Cronobacter sakazakii. Additionally, no unopened, distributed Abbott infant formulas have ever tested positive for this bacterium.

The agreement resolves lawsuits brought by the Department of Justice, as well as by certain relators and the Attorneys General of several states. Abbott maintains its commitment to the safety and quality of its products, stating that Cronobacter bacteria are naturally found in the environment and can contaminate dry foods, including powdered infant formula.

The company advises parents and caregivers to take several precautions to prevent Cronobacter infection, such as breastfeeding if possible, cleaning and sanitizing infant feeding items, and keeping hands and surfaces clean. Abbott retains samples from all lots of all products distributed and tested samples from the lots corresponding to the infants involved in the recall, which all tested negative.

In the past, multiple infant formula manufacturers have reported Cronobacter-related findings in their manufacturing facilities, and in one instance, in finished, distributed product. The CDC has stated that the cases linked to Abbott’s 2022 recall did not meet the definition of an outbreak and found no definitive link between the Sturgis facility and the cases under investigation.

Abbott, which operates with a focus on diagnostics, medical devices, nutritionals, and branded generic medicines, continues to prioritize the safety and quality of its products. The company remains committed to earning and maintaining the trust of caregivers who depend on it.

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