Pfizer Inc. and its former supplier Tris Pharma reached a $41.5 million settlement with the state of Texas to resolve claims that the ADHD medication Quillivant XR failed to meet quality‑control standards. The agreement was announced on Nov 19, 2025 and settles allegations that the drug’s manufacturing process did not comply with state regulations.
The lawsuit, filed by Texas authorities in Nov 2023, traces misconduct back to 2012‑2018, when Pfizer acquired Quillivant XR from NextWave and later transferred production to Tris Pharma. The complaint accuses the companies of manipulating quality‑control testing during that period, a claim that could jeopardize patient safety and regulatory compliance.
In 2018 the FDA issued a warning letter to Tris Pharma for violations of current good manufacturing practices, noting that multiple lots of Quillivant XR failed dissolution testing and that the company did not investigate product failures adequately. The settlement resolves claims that the drug was supplied to Texas’s Medicaid program, which serves children from low‑income families.
Pfizer’s 2024 revenue of $63.6 billion and its 2025 guidance of $61‑$64 billion place the settlement at a fraction of the company’s annual top line. Management has previously stated that the allegations did not affect product safety and that the state’s case had no merit. The payment therefore is unlikely to materially affect Pfizer’s financial performance, but it underscores ongoing regulatory scrutiny and the importance of stringent quality controls in its manufacturing operations.
The settlement highlights the operational risks inherent in large‑scale pharmaceutical production and signals that regulators will continue to scrutinize supply‑chain partners. Pfizer’s decision to resolve the dispute rather than pursue a protracted legal battle reflects a strategic choice to mitigate reputational risk and preserve its standing with state regulators.
While the $41.5 million payout is modest relative to Pfizer’s scale, the case serves as a reminder that quality‑control lapses can trigger costly settlements and regulatory action. The company’s focus on maintaining compliance and addressing past deficiencies will be closely watched by regulators and investors alike.
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