Plaintiff alleges Defendant and affiliates produced and sold Breckenridge duloxetine contaminated with n‑nitroso‑duloxetine (NDLX), a nitrosamine linked to cancer. Plaintiff maintains the impurity made the generic duloxetine—FDA‑approved for several adult and pediatric indications—illegal to market and economically worthless, causing buyers financial injury. Plaintiff asserts FDCA/FDA violations because NDLX exceeded acceptable intake (AI) limits and cGMP, citing a 2024 recall of hundreds of thousands of bottles. Defendant denies these assertions, arguing AI limits did not apply when the product was made, not all lots exceeded those limits, and the product retained its value; Plaintiff disputes those defenses.