WASHINGTON — The Justice Department spent years investigating Abbott Laboratories over how it managed a baby formula facility where potentially deadly bacteria was discovered and suspected of causing infant deaths, worsening a national shortage. Some prosecutors believed they had evidence to criminally charge the company under the Food, Drug and Cosmetic Act, according to people familiar with the matter. Some supervisors also thought it was a strong case, the people said.
Top decision makers instead closed the probe, opting for a civil resolution focused on clawing back money Abbott earned by selling formula through federally funded child-nutrition programs. The closure follows a Trump-era policy shift on corporate prosecution detailed in a May 2025 executive order.
MSI previously reported that the FDA announced in April that testing from 2023 to 2025 found reassuringly low levels of heavy metals, pesticides, and other contaminants in commercial infant formula, a finding separate from the Abbott plant investigation. Read the full story.
Trump in May 2025 issued an executive order calling for minimizing the use of criminal sanctions where civil penalties could be used instead. Prosecution should be reserved for cases in which companies or people “willingly choose not to comply, thereby causing or risking substantial public harm,” the White House wrote at the time.
A Justice Department spokeswoman confirmed the probe was closed, saying criminal charges would have been heavy-handed and that officials instead resolved their concerns through a related civil lawsuit. “Ensuring the safety of our nation’s food supply is a top priority for the Trump administration, however, this Department of Justice does not believe in regulation by prosecution,” the spokeswoman said.
Prosecutors had been considering a misdemeanor charge against Abbott for violating the Food, Drug and Cosmetic Act and a separate count for misleading the government, some of the people said. They also were considering charging at least one individual, the people said.
FDA inspectors in early 2022 found traces of the bacteria cronobacter sakazakii at the Sturgis plant, including on equipment very close to infant formula containers, as well as a long list of other problems. They found standing water in multiple locations and employees who worked directly with baby formula but did not adequately wash their hands. The company had found the bacteria repeatedly in prior years. A former FDA official later testified to Congress that five different strains of the bacteria had been found at the plant, calling the facility “out of control.”
Cronobacter infections had sickened four babies who drank Abbott formula produced at the plant, two of whom died. The company denied a link between the plant’s conditions and the children who fell ill, noting that genetic testing by the Centers for Disease Control and Prevention found that the bacteria that infected two of the infants were not closely genetically linked to samples found at the plant. No unopened, distributed Abbott infant formulas have tested positive for the bacteria, a company spokesman said.
FDA officials told lawmakers that the cronobacter found in the plant remains a “serious concern” because such facilities are one of the most likely sources of contaminated formula.
Acting Attorney General Todd Blanche last year said he supports penalizing companies when prosecutors also can identify and charge people behind the wrongdoing, but he has criticized going after companies when prosecutors do not have enough evidence to charge individuals, or pursuing shaky cases that do not appear to be winnable at trial. Trump has nominated Blanche to the permanent position, and senators are expected to press him about his views on enforcement during a confirmation hearing next month.
The company’s defense lawyers included Mark Filip, who served as deputy attorney general under President George W. Bush. Filip last year also urged the Justice Department to overhaul the consumer-focused office that steered the investigation and to remove its ability to bring criminal cases, people familiar with those discussions said.
The Justice Department said in November, as part of the related civil lawsuit, that Abbott “knowingly” failed to follow manufacturing standards to protect against the risk of contamination. That suit, joined by 31 states, alleged that Abbott had a “culture of concealment” at Sturgis and “withheld information from FDA related to the presence of microorganisms in the Sturgis facility.” The department and Abbott have reached a settlement to resolve that case, which was disclosed to a court last month. The terms were not revealed.
The executive order “brought a big sigh of relief to CEOs across the country,” said Bill Marler, a lawyer who represents victims of food-borne illnesses. The use of criminal penalties “did keep CEOs and people in the food business on their toes.”