Somerset agrees to $4 million Medicare drug-labeling settlement
DOJ says Somerset Lifesciences agreed to pay $4 million over Medicare Part D payments for generic olopatadine after its brand-name counterpart became available over the counter.
What the record says
The October 16 announcement describes a settlement of common-law claims involving the 0.1% ophthalmic solution. DOJ alleges Somerset continued prescription-only labeling after the brand-name drug switched to over-the-counter status in February 2020, causing Medicare to pay claims for an ineligible product.
Source details and supporting locations.
Practical next step
Read the Justice Department announcement for the scope of the resolution. It does not announce a consumer refund application.
Limits and what is not established
Except for admissions in the settlement agreement, the resolved claims remain allegations; DOJ says there has been no determination of liability. This announcement does not establish an individual beneficiary’s coverage or direct anyone to change medication.
Sources checked October 17, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Department of Justice: original information