Abbott Laboratories, the maker of the popular infant formula Similac, will pay nearly $385 million to settle claims that it knowingly sold formula manufactured in facilities that did not meet safety requirements.
The settlement, announced on Monday by the Justice Department, follows years of scrutiny of a plant Abbott managed in Sturgis, Mich., that produced a sizable share of the nation’s formula supply. In 2022, Abbott initiated a recall of powdered formulas manufactured at the plant, after federal health officials linked the products to four infants who were hospitalized with rare bacterial infections, two of whom died.
Production at the facility was halted, contributing to a nationwide formula shortage that lasted for months.
In a statement provided to The Times on Monday, the company, which did not admit liability or fault in the settlement, noted that “no unopened, distributed Abbott infant formulas have ever tested positive” for the bacteria that sickened the babies, including containers from the homes of the infants.
“We make infant formula with the same care we would for our own families and are deeply committed to earning and maintaining caregivers’ trust,” the company said.
The federal government’s complaint detailed unsanitary conditions at the Michigan plant, including roof leaks, deteriorating equipment and inadequate cleaning procedures.
Instead of fixing the roof leaks, the department said, Abbott installed umbrellas, which diverted water from production areas but created a wet environment ripe for bacterial growth. The company’s spray dryers, which were used to turn liquid formula into powder, had cracks and pits, which increased the risk of contamination, the complaint said, and Abbott ran more batches of formula through the dryers between cleaning cycles than was safe.
The Justice Department also claimed that Abbott purposefully chose not to test for bacterial contamination and that, when the company did perform tests, it did not share positive results with the Food and Drug Administration.
In a 2022 consent decree reached with the Justice Department, Abbott agreed to replace the plant’s roof, address sanitation protocols and take other corrective steps, though it did not admit liability. In a hearing before a House panel that year, an Abbott representative said it prioritized “safety and compliance in our plants.”
The Abbott recall underscored broader concerns about the safety and oversight of the U.S. infant formula supply. In 2025, the formula company ByHeart, whose products were linked to an infant botulism outbreak, shut down its Pennsylvania plant after inspectors found safety violations, including mold in a clean-water tank and dead insects in a production area. The company recalled all lots of its formula.
Nearly $349 million of the Abbott settlement funds will go to the federal government and just over $36 million will go to state Medicaid and W.I.C. programs that purchased Abbott’s formula. Three whistle-blowers who first filed complaints about the plant will receive $69 million.
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