Abbott: No evidence links formula to 2022 infant illnesses

Abbott Laboratories is restating its position that numerous government investigations and scientific analyses have failed to establish a link between its infant formula and the illnesses and deaths that prompted the 2022 recall. The company asserts that its products did not cause the health issues that led to the widespread shortage.

The U.S. Food and Drug Administration (FDA) reported in March 2022 that unopened formula samples collected from affected infants' homes tested negative for Cronobacter sakazakii. Subsequent analyses by the Centers for Disease Control and Prevention (CDC) concluded there was no definitive link between bacterial strains found at Abbott's Sturgis, Michigan, facility and those identified in sick infants. Genetic sequencing data also did not match strains from the facility with those found in infants.

Abbott states it has fully cooperated with all governmental inquiries related to the recall, across multiple administrations. The Securities and Exchange Commission (SEC) closed its investigation without taking enforcement action, and the Federal Trade Commission (FTC) has taken no action. The company recently announced a settlement with the U.S. Department of Justice regarding related civil matters, noting the settlement does not represent any finding of fault or liability.

The company highlights that Cronobacter is ubiquitous in the environment, including homes and manufacturing settings, and its presence in production facilities is not unique to Abbott. Abbott emphasizes its rigorous testing protocols for Cronobacter and Salmonella on all powdered infant formula batches before release, despite facing significant scrutiny while other manufacturers have also reported environmental findings. Abbott maintains that scientific analysis, testing, and government review consistently conclude its formula was not the cause of the illnesses.