Abbott Park, Illinois, September 14, 2026
Abbott has reached an agreement with the U.S. Department of Justice (DOJ) and other parties to resolve previously disclosed claims related to the company’s manufacturing and 2022 recall of powdered infant formula produced at its facility in Sturgis, Michigan. Under the agreement, Abbott will pay a total of $385 million to resolve the claims. The company emphasized that the settlement does not represent a finding of fault or liability. The development brings a major legal and regulatory chapter surrounding the 2022 infant formula recall toward resolution while highlighting the continuing importance of food safety, manufacturing controls, product testing and quality assurance in infant nutrition.
Abbott Reaches $385 Million Resolution Agreement
The agreement addresses an investigation and lawsuit brought by the U.S. Department of Justice, as well as lawsuits filed by certain relators and the attorneys general of several states concerning Abbott’s Sturgis manufacturing facility and the 2022 powdered infant formula recall. Abbott stated that it will pay $385 million as part of the resolution. The company also noted that the U.S. government’s criminal investigation into the matter has been closed, providing an important regulatory development following years of scrutiny surrounding the recall. The 2022 recall involved powdered infant formula manufactured at Abbott’s Sturgis, Michigan, facility. The recall and subsequent investigation generated significant attention around potential contamination involving Cronobacter sakazakii, a bacterium that can contaminate powdered foods and infant feeding equipment. Infant formula manufacturing requires stringent controls because newborns and young infants can be particularly vulnerable to serious infections. The episode therefore remains an important case study in food manufacturing quality systems, microbiological testing and consumer safety.
Testing and Cronobacter Findings
Abbott’s announcement highlighted testing conducted by government regulators during the investigation. According to the company, no unopened, distributed Abbott infant formula has ever tested positive for Cronobacter sakazakii. Abbott also stated that government testing of unopened product from the homes of infants under investigation at the time of the 2022 recall was negative for the bacterium. The company cited previous statements from the FDA and CDC concerning the investigation and said the CDC ultimately found no definitive link between the Sturgis facility and the clinical cases under investigation. Abbott further reported that retained samples from product lots associated with the investigated cases tested negative for Cronobacter sakazakii and Salmonella Newport. The company’s announcement also described genetic sequencing information from available clinical and environmental samples. According to Abbott, samples from two infants did not match strains found at the Sturgis facility, while other testing identified potential sources of Cronobacter in household environments. These details form part of Abbott’s explanation of the scientific and regulatory findings surrounding the recall.
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Food Safety Remains Critical in Infant Nutrition
The resolution underscores the importance of comprehensive food safety and quality management systems across the infant nutrition industry. Powdered infant formula can be exposed to environmental microorganisms, making manufacturing hygiene, environmental monitoring, testing, equipment sanitation and appropriate product handling essential components of production. Abbott said it remains focused on the safety and quality of its products and on maintaining the trust of caregivers who rely on its infant nutrition products. The company also reiterated guidance concerning safe preparation and handling of powdered infant formula, including maintaining clean hands and surfaces, properly cleaning and sanitizing feeding equipment, and preparing and storing formula safely. The CDC has noted that Cronobacter can occur naturally in the environment and can contaminate dry foods and feeding equipment, emphasizing that food safety extends beyond manufacturing facilities into household preparation and handling practices. For the broader food and healthcare industries, Abbott’s agreement demonstrates how product recalls, regulatory investigations, microbiological testing and legal proceedings can intersect in the management of food safety incidents. The resolution also highlights the importance of traceability, retained-product testing, environmental monitoring and transparent regulatory engagement when concerns arise involving products intended for vulnerable populations. Abbott said that as it moves forward, the company remains focused on serving families who depend on its products. The resolution marks a significant development in the company’s response to the 2022 infant formula recall, while continued attention to manufacturing quality and food safety remains essential for maintaining confidence in infant nutrition products.
Source: Abbott press release
