Abbott Formula Recall Settlement
Abbott Laboratories agrees to a $385 million settlement following a major infant formula recall.
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Key Points
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The settlement’s payment is divided into $348,700,868 for the federal government and $36,298,172 for state Medicaid and WIC programs. WIC covers more than half of all infant formula purchased nationwide.
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The allegations also involved Abbott’s Casa Grande, Arizona, facilities, which prosecutors said produced infant formula and nutritional-therapy products that failed to meet federal safety and legal requirements.
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According to the federal complaint, Abbott used temporary “roof leak umbrellas” rather than permanently repairing recurring leaks, continued operating cracked spray dryers, ran additional batches between scheduled cleanings and allegedly skipped bacterial testing to avoid positive contamination findings.
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The complaint alleged that Abbott withheld contamination records from FDA inspectors during reviews conducted in 2019 and 2022.
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Acting Deputy Attorney General Trent McCotter called the agreement “a victory for American families” and said it made clear that “the safety of our children is not negotiable.” Abbott said it was “deeply committed to earning and maintaining caregivers’ trust.”
Abbott Laboratories agreed to pay $385 million to settle federal and state claims tied to its 2022 infant formula recall and the closure of its Michigan plant, the nation's largest formula facility Forbes. Prosecutors alleged Abbott submitted false claims for products made under unsafe conditions — including roof leaks, damaged equipment and inadequate testing — that posed contamination risks Bloomberg Law.
The recall affected Similac and other brands, triggering a nationwide formula shortage CBS News. Abbott denied fault and said no unopened, distributed products tested positive for the bacteria under investigation. The settlement contains no admission of liability from the company Detroit News.
How Abbott's Safety Failures Played Out
At the Sturgis, Michigan plant, Abbott used temporary plastic tarps instead of permanently fixing roof leaks that kept recurring bgov. The company continued running cracked spray dryers, added extra batches between scheduled cleanings, and allegedly skipped bacterial testing to avoid finding contamination Forbes.
Prosecutors also alleged Abbott withheld contamination records from FDA inspectors during reviews in 2019 and 2022 Bloomberg Law. The company's Casa Grande, Arizona facilities also produced infant formula and nutritional products that failed to meet federal safety requirements, according to the federal complaint.
The Settlement's Split and Impact on Families
The $385 million payment breaks down as $348.7 million to the federal government and $36.3 million to state Medicaid and WIC programs bgov. WIC covers more than half of all infant formula purchased nationwide, making the payment significant for low-income families who depend on the program.
Acting Deputy Attorney General Trent McCotter said the deal was "a victory for American families" and emphasized that "the safety of our children is not negotiable." Abbott responded by saying it remains "deeply committed to earning and maintaining caregivers' trust."
Abbott's Denial and the Investigation's Close
Abbott maintained that testing found no definitive link between the Sturgis plant and reported infant illnesses CBS News. The company stressed that the settlement allows it to resolve claims without admitting wrongdoing or liability.
The criminal investigation closed under President Donald Trump's administration. The Sturgis facility reopened in June 2022 after the initial recall, and it continues operating as one of the nation's key formula production sites Forbes.
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