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Abbott Settles False Claims Act Allegations Related to Powder Infant Formula and Nutritional Therapy Products

Abbott LaboratoriesSeptember 14, 2026Connecticut Attorney General

Penalty Amount

$384,192,156

Summary

Connecticut joined 39 other states and the federal government in a $384 million False Claims Act settlement with Abbott Laboratories over allegations that the company failed to manufacture powder infant formula and nutritional therapy products in compliance with federal and state requirements at its Sturgis, Michigan, and Casa Grande, Arizona facilities. Abbott allegedly manufactured formula in conditions that risked microorganism contamination and failed to disclose contamination test results to the FDA during 2019 and 2022 inspections. The settlement resolves claims that Abbott caused false claims to be submitted to the WIC program and state Medicaid programs between January 1, 2018, and December 31, 2022.

Remedy

Abbott will pay $348,700,868 to the United States to resolve federal False Claims Act allegations and $35,491,288 to participating states for claims related to their state Medicaid programs, for a total of $384,192,156. Connecticut's share attributable to its Medicaid program is $936,629.70.

Monetary Penalty

Contract Impact

This enforcement action centered on Abbott's failure to meet 'statutory, regulatory, and contractual requirements' in manufacturing products sold to government programs, so in-house teams (particularly in healthcare, food, and manufacturing) should review government contracts and vendor agreements for compliance-with-law representations, quality control and manufacturing standards clauses, and warranties of regulatory conformity. Contracts should include explicit obligations to disclose adverse test results, inspection findings, or contamination events to customers and regulators promptly, along with audit rights allowing counterparties to verify manufacturing facility compliance. Vendor agreements with suppliers to regulated facilities should flow down FDA (and analogous) manufacturing requirements, and customer contracts for government-funded programs (WIC, Medicaid) should contain certifications, indemnification for false claims liability, and cooperation obligations during regulatory inspections.

Contract Search Terms

False Claims Actmanufacturing complianceFDA inspection disclosurequality control requirementscontamination testingregulatory compliance certificationcontractual requirementsgovernment contract representationsproduct safety warrantiestest result disclosure

Laws Cited

False Claims ActState False Claims Statutes

Violation Types

Entity Details

Entity

Abbott Laboratories

Industry

Healthcare

Multistate Coalition

Official Sources

Source Evidence

Entity Name
"an agreement with Abbott Laboratories (Abbott) to settle allegations that the company caused false claims to be submitted to federal and state programs"
Fine Amount
"will pay $348,700,868 to the United States to resolve the False Claims Act allegations and $35,491,288 to participating States for claims related to their state Medicaid programs"
Laws Cited
"initially filed in 2022 in the United States District Court for the Western District of Michigan under the federal False Claims Act and various state false claims statutes"
Violation Types
"Abbott allegedly failed to maintain its manufacturing equipment, failed to control the presence of water that put the products at increased risk of microorganism contamination, and, in certain instances, failed to disclose test results indicating the presence of microorganism contamination"
Is Multistate
"Connecticut has joined 39 other states and the federal government to reach an agreement with Abbott Laboratories"

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Abbott Laboratories agreed to pay more than $384 million — including $977,558 to Oregon — to resolve allegations that it sold powder infant formula and nutritional therapy products made in unsafe manufacturing conditions to Medicaid and food assistance programs such as WIC between January 2018 and December 2022. Investigators found Abbott failed to maintain manufacturing equipment and control water at its Sturgis, Michigan, and Casa Grande, Arizona, facilities, and withheld test results showing contamination during FDA inspections in 2019 and 2022. The settlement was negotiated by the National Association of Medicaid Fraud Control Units on behalf of the federal government and 39 states.

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