DOJ Dropped Secret Criminal Charges Against Baby Formula Giant Abbott Despite Claims Contaminated Milk 'Sickened And Killed' Infants

Federal prosecutors who spent more than three years assembling a criminal case against the largest baby formula maker in the United States have abandoned it, even after gathering what investigators viewed as a substantial body of evidence.

The Justice Department has closed its criminal investigation into Abbott Laboratories over the handling of its Sturgis, Michigan plant, the source of a 2022 outbreak of potentially deadly bacteria and a national formula shortage.

Prosecutors have chosen to pursue civil penalties rather than charges against the company or its executives. The decision, first reported by The Wall Street Journal, brings a muted end to one of the most closely watched corporate food-safety inquiries in recent memory.

Inside the Sturgis Outbreak That Triggered a Federal Inquiry

The investigation grew out of events at a single facility on North Centerville Road in Sturgis, which at its peak produced roughly a fifth of the nation's infant formula. In late January 2022, the FDA carried out a for-cause inspection and detected Cronobacter sakazakii, a bacterium that can cause fatal sepsis or meningitis in infants, in several areas of the plant.

Abbott voluntarily recalled Similac, Alimentum and EleCare products and shut the site down, choking off supply across the country.

Four infants who had consumed formula made at Sturgis fell ill with Cronobacter infections, and two of them died, according to the FDA and CDC accounts cited throughout the litigation. The Justice Department's civil complaint, filed in May 2022, alleged that the products were adulterated because they were made under insanitary conditions and in violation of good manufacturing practice rules.

That complaint named the company alongside three Abbott managers: quality assurance vice-president Lori J. Randall, Sturgis quality director Keenan S. Gale and site director TJ Hathaway.

The Evidence Trail Prosecutors Spent Years Building

The record that accumulated around Sturgis was unusually detailed for a food-safety matter. The consent decree, entered in the Western District of Michigan as case 1:22-cv-00441, permanently enjoined Abbott from producing adulterated formula and required independent expert oversight, environmental monitoring and rapid recalls if pathogens reappeared.

It carried financial teeth, with penalties of up to £23,000 ($30,000) per day for violations, capped at roughly £3.8 million ($5 million) a year.

Sworn testimony sharpened the picture. At a congressional hearing, the FDA's leadership described the conditions inspectors encountered as 'egregiously unsanitary' and the inspection results as 'shocking,' telling lawmakers the agency had lost confidence in Abbott's safety culture.

A House oversight transcript records officials reading the FDA's finding that Abbott 'did not establish a system of process controls designed to ensure that infant formula does not become adulterated,' and that the company failed to keep formula-contact surfaces clean.

A former employee had also gone to regulators well before the recall. The whistleblower complaint, filed with the FDA in 2021, alleged that Abbott management falsified records, released untested formula and sought to mislead inspectors during an earlier audit. Company documents reviewed by investigators showed Cronobacter had turned up in the plant's own testing in 2019 and 2020, as later detailed in reporting by ProPublica drawing on FDA records.

Why the Genetic Link Question Loomed Over Any Charges

One evidentiary gap shadowed the entire matter. Federal scientists were never able to match the Cronobacter strains found at Sturgis to the bacteria that sickened the infants, and the two patient samples that were available did not match each other either. That absence of a definitive genetic link has been Abbott's central defence from the outset.

Abbott has consistently maintained that no unopened, distributed Abbott formula has ever tested positive for Cronobacter sakazakii, and that the bacteria found during the inspection sat in non-product contact areas of the sprawling facility. In a detailed rebuttal published in 2025, the company said it had addressed every FDA observation from 2021 and 2022 and disputed the claim that Sturgis was egregiously unsanitary, noting the bacterium is common in ordinary kitchens and feeding equipment. That scientific uncertainty made a criminal case carrying potential prison time for individuals far harder to sustain than a civil resolution.

Closing the criminal file does not lift the legal pressure on Abbott. The 2022 consent decree remains in force, and the company still faces a separate and sprawling wave of civil litigation over necrotising enterocolitis, a bowel disease, in cases brought by families of premature infants. In April 2026, a Cook County jury ordered Abbott to pay damages to four families, a verdict the company has said it will appeal on the grounds that science was ignored.

For the parents who buried children after the Sturgis outbreak, the move to civil penalties lands as a quiet anticlimax to a saga that emptied store shelves and shook trust in a household brand. Whether the financial settlement now being pursued will satisfy them, or Congress, is a question the paperwork cannot answer.

A case that began with the deaths of infants and a pile of federal evidence has ended not with a courtroom reckoning, but with a cheque.