Federal officials announced this week that a Fortune 500 healthcare devices and medical supplies company has agreed to pay just shy of $385 million to resolve allegations involving issues with its production of baby formula.

The case stemmed from a November 2025 complaint alleging that Abbott Laboratories had caused federal government programs to purchase powder infant formula manufactured at the company’s Sturgis, MI facility – the largest of its kind in the country – despite the products’ failure to meet statutory, regulatory, and contractual requirements, creating what officials called an “unacceptable risk of microorganism contamination” that “significantly impacted the products’ reliability, quality, and safety.”

“Today’s settlement is a victory for American families and makes clear the safety of our children is not negotiable,” Acting Deputy Attorney General Trent McCotter said in a statement. “Abbott will pay a substantial sum to resolve serious allegations it violated federal health and safety requirements designed to protect babies. The Justice Department will act decisively against anyone who puts American families at risk and ensure misconduct carries serious consequences.”

“No company should be gambling on the health and safety of our Nation’s infants by allowing unsanitary conditions to persist at a facility manufacturing baby formula,” Associate Attorney General Stanley E. Woodward, Jr. added. “The Department will hold accountable bad actors that knowingly...

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