--- title: Abbott to Pay Nearly $385 Million to Settle Claims Tied to 2022 Baby Formula Recall description: The Justice Department says Abbott will pay nearly $385 million to settle allegations tied to its 2022 infant formula recall, with no finding of fault. author: Darie Nani (Editor-in-Chief) updated: 2026-09-14T19:31:22.098Z canonical: https://richhealthmagazine.com/article/abbott-385-million-2022-formula-recall-settlement image: https://cdn.nanimediahouse.com/pexels-a-parent-prepares-a-baby-bottle-with-formula-on-a-wooden-tab-7491271.jpg categories: Health content_type: News region: United States publication: Rich Health Magazine schema_type: Article --- The Department of Justice announced on September 14, 2026 that Abbott will pay nearly $385 million to settle allegations tied to its manufacturing practices and the February 2022 recall of powdered infant formula made at its plant in Sturgis, Michigan. For parents who spent that spring driving from store to store looking for Similac, the settlement puts a formal end to the government's case over the events behind the shortage. The total is $384,999,040, according to the [Justice Department](https://www.justice.gov/opa/pr/abbott-agrees-pay-over-384m-settle-allegations-related-contaminated-infant-formula). Of that, $348,700,868 goes to the federal government and $36,298,172 goes to state Medicaid and WIC programs, which help low-income families buy formula. Three former Abbott employees who brought the case forward as whistleblowers will receive about $69 million. The agreement is a civil settlement under the False Claims Act, and the DOJ states plainly that the allegations are "allegations only" with "no determination of liability." Abbott does not admit wrongdoing. The DOJ also notes that the government has previously indicated it closed its criminal investigation into the matter, and no criminal charges were brought. The DOJ alleges that Abbott caused false claims to be submitted to federal and state programs between January 2018 and December 2022 by failing to make the formula in line with federal and state requirements at its Sturgis and Casa Grande, Arizona plants. As described in the government's complaint, roof leaks were common at the Sturgis plant, letting water run and drip over equipment, and Abbott used temporary fixes rather than addressing the causes. The complaint also says the company kept running spray dryers, which turn liquid formula into powder, after documenting cracks and pits in them. The DOJ says both problems raised the risk of microorganism contamination. The DOJ further alleges that Abbott "intentionally did not test for bacterial growth to avoid obtaining positive test results showing contamination," and that in certain instances where testing did show contamination, the company failed to disclose those results to the FDA during inspections in 2019 and 2022. Abbott has not admitted to any of these allegations. The recall at the center of the case began on February 17, 2022, when Abbott voluntarily pulled Similac, Alimentum and EleCare powdered formula produced at Sturgis. The FDA had opened an investigation after four infant illnesses were reported, three involving the bacterium Cronobacter sakazakii and one involving Salmonella Newport. All four infants were hospitalized, and the cases spanned Minnesota, Ohio and Texas. The CDC later confirmed those four cases and reported that two of the infants, both in Ohio, died. FDA inspectors found that the Sturgis plant itself was contaminated, reporting five environmental samples at the facility that tested positive for Cronobacter sakazakii, representing several different strains. The CDC's whole-genome sequencing did not find the bacteria in the sick infants to be closely related to the Cronobacter strains found at the Sturgis plant, so investigators could not establish a genetic link between the specific illnesses and the facility. That absence of a proven link does not mean the plant was clean, because the FDA found it was contaminated. Abbott points to a related FDA finding from early March 2022, when the agency confirmed that unopened product taken from the homes of the infants under investigation tested negative for Cronobacter sakazakii. Between December 1, 2021 and March 3, 2022, the FDA received nine reports of infant deaths involving babies who had been fed Abbott powdered formula from Sturgis. Only two of those nine were confirmed as Cronobacter-related. The other seven were reported to the agency but not confirmed to have been caused by the formula. Abbott supplied roughly 40 percent of US infant formula, and the production pause at Sturgis was the main driver of the shortage that followed. Store shelves emptied across the spring of 2022. By fall 2022, about 35 percent of parents reported difficulty getting formula, according to Census Bureau figures, a share that fell to about 20 percent by summer 2023. In announcing the deal, the DOJ called it "a victory for American families" and said "the safety of our children is not negotiable." The formula sold today is not the subject of the settlement, which concerns conditions and conduct the DOJ alleges occurred through 2022. ## FAQ **Q: Why was there a baby formula shortage in 2022?** Abbott supplied roughly 40 percent of US infant formula, and when it paused production at its Sturgis, Michigan plant after the February 2022 recall, supply dropped sharply. Some parents were still reporting difficulty finding formula into 2023. **Q: Which Abbott formula was affected in 2022?** The recall covered powdered Similac, Alimentum and EleCare made at the Sturgis plant. It did not cover Abbott's liquid formulas or products from its other plants, but because Sturgis was so large, its shutdown still drove a nationwide shortage. **Q: Did the settlement mean the formula was unsafe, and is Similac safe now?** The settlement resolves DOJ allegations about manufacturing conditions through 2022 without any finding of fault, and Abbott does not admit wrongdoing. It concerns the plant and the recalled product from that period, not the formula on shelves today. FDA testing found the Sturgis facility itself was contaminated, but unopened product taken from the sick infants' homes tested negative for Cronobacter. **Q: What is Cronobacter, and how does it relate to these cases?** Cronobacter sakazakii is a bacterium that can cause rare but serious infections in infants, especially newborns and premature babies. FDA inspectors found several strains of it in environmental samples at the Sturgis plant. The CDC's genetic sequencing did not find a close match between those plant strains and the bacteria in the sick infants, so investigators could not prove a direct link between the specific illnesses and the facility. **Q: Does the settlement mean Abbott admitted the formula caused the deaths?** No. This is a civil settlement, and the DOJ states the allegations carry no determination of liability. Abbott does not admit wrongdoing. Of nine infant deaths reported to the FDA during the investigation window, only two were confirmed as Cronobacter-related, and the CDC found no proven genetic link between the patient cases and the Sturgis plant.