The Baby Formula Investigation Had Evidence Against Abbott Laboratories but DOJ Dropped It

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Abbott Baby Formula
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The Justice Department’s decision to close a criminal case tied to the 2022 baby formula crisis revisits one of the most disruptive food-supply failures of the pandemic era. This time, the focus is Abbott Laboratories and its Sturgis, Michigan, plant, where federal investigators previously documented contamination concerns and operational failures.

DOJ closes the Abbott criminal case tied to the 2022 formula crisis

The Justice Department has closed its criminal investigation into Abbott Laboratories over how it operated its baby formula plant in Sturgis, Michigan, according to a June 28 Reuters report that cited the Wall Street Journal. Reuters reported that prosecutors had considered a misdemeanor charge under the federal Food, Drug and Cosmetic Act and a separate count tied to allegedly misleading the government before dropping the criminal case and shifting toward civil penalties.

The investigation stemmed from the plant shutdown and recall that helped trigger the national formula shortage in 2022. Abbott recalled powdered formula made at the Sturgis facility on February 17, 2022, including Similac, Alimentum and EleCare, and later expanded that recall to one lot of Similac PM 60/40 on February 28, 2022, according to the FDA. The CDC said the broader federal investigation was tied to reports of infant illnesses after formula consumed from the Sturgis plant.

Federal records from the FDA said inspectors found positive Cronobacter results in environmental samples at the facility and documented adverse inspectional observations during the 2022 inquiry. The FDA has also said its investigation revealed insanitary conditions and the presence of five different strains of Cronobacter sakazakii within the plant. Abbott has repeatedly said there was no conclusive evidence directly linking its finished formula products to the reported infant illnesses.

Michigan is the key geography in this case because the Sturgis facility was the site of the shutdown, recall and later reopening under federal oversight. The plant’s closure in February 2022 became a national supply issue, but the factory itself is in southwest Michigan, making the state central to every regulatory and legal development tied to the case.

What is confirmed is that the criminal investigation focused on conduct connected to the Sturgis plant and that the Justice Department has now ended that criminal track, according to Reuters and other published reports. What is not publicly known is whether the government will disclose a fuller account of the evidence prosecutors reviewed or what precise civil penalties, if any, may now be pursued. Abbott has not released any new Michigan-specific operating changes in connection with the reported end of the criminal probe.

The plant’s importance to supply helps explain why developments in Sturgis drew national attention. AP reported during the 2023 investigation that Abbott was one of four companies producing about 90% of U.S. baby formula. Court filings cited in later shareholder litigation said Abbott produced about 40% of infant formula consumed in the United States before the recall, underscoring how a single Michigan facility became a chokepoint for families nationwide.

The context for the investigation reaches back to late 2021 and early 2022, when the FDA, CDC and state partners began examining complaints involving infant illnesses associated with formula from Abbott’s Sturgis facility. The FDA said the investigation included four reports of Cronobacter infections in infants and one complaint involving Salmonella Newport, while the CDC said two patient samples were genetically sequenced for comparison against environmental samples from the plant.

The FDA has said its inspection uncovered conditions inconsistent with a strong food-safety culture, while a later agency review described outdated systems and training gaps that also affected the government’s response. In separate public statements, Abbott said finished-product testing during the inspection was negative for Cronobacter and Salmonella and maintained that no conclusive evidence tied its formulas to the illnesses. Those competing accounts shaped years of scrutiny from regulators, lawmakers and litigants.

For parents and residents, the latest development does not reopen the 2022 recall, but it does mark the end of one major federal enforcement path. The practical takeaway is that the criminal probe is over while possible civil action remains unresolved, based on the Reuters report. The Sturgis plant has continued operating under corrective requirements put in place after the 2022 shutdown, and federal oversight of infant formula safety remains a live issue for regulators and manufacturers.

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