What the evidence says about Abbott and the 2022 infant formula recall

Families deserve a discussion about infant nutrition and safety grounded in science. Four years after the 2022 infant formula recall, years of government investigations, scientific review and testing, the facts are clear: There is no evidence that Abbott formula caused the illnesses or deaths that prompted the 2022 recall.

Testing and genetic sequencing did not identify a connection between Abbott formula and the reported illnesses:

• The FDA confirmed in March 2022 that unopened formula collected from the homes of infants involved in the investigation tested negative for Cronobacter sakazakii.
  
  
• The CDC later concluded there was no definitive link between the Sturgis facility and the cases under investigation. A CDC scientist further noted that one case was likely associated with contamination that occurred in the home after the product was opened.
  
  
• Available genetic sequencing data showed that strains identified at the Sturgis facility did not match the strains found in affected infants.
  
  
• No unopened, distributed Abbott infant formula has ever tested positive for Cronobacter sakazakii.

Abbott has fully cooperated with every government inquiry related to this matter across administrations of both political parties, providing extensive records and access to dozens of employees. The SEC closed its investigation without taking enforcement action, and the FTC has taken no action following its inquiry. Today, Abbott announced it has resolved related civil matters with the United States Department of Justice. The settlement does not represent any finding of fault or liability.

Cronobacter is ubiquitous in the environment, including homes, manufacturing environments and many other settings. Its presence in manufacturing environments is not unique to Abbott. In fact, since 2022, multiple infant formula manufacturers have reported Cronobacter-related findings in manufacturing facilities – and, in one instance, in finished, distributed product. None have been subjected to this level of scrutiny.

Before Abbott releases any powdered infant formula for sale in the United States, it conducts rigorous testing for Cronobacter and Salmonella. Product is not released until every batch undergoes microbial testing, analytical and microbiological review, sanitation verification and final batch certification.

Nothing is more important than the safety and quality of our products. For more than 100 years, Abbott has helped nourish babies around the world. Years of scientific analysis, testing and government review point to a consistent conclusion: Abbott formula did not cause the illnesses or deaths that led to the 2022 investigation.

As we move forward, we remain focused on serving the families who depend on us every day.