Overview
- Breckenridge Pharmaceuticals voluntarily recalled the affected lots after Monday's FDA notices showed laboratory tests detected N‑nitroso‑duloxetine above the agency's interim acceptable intake.
- The recall covers more than 370,000 bottles distributed in the U.S., including about 360,000 bottles of 60 mg capsules and 14,000 bottles of 30 mg capsules produced by Towa Pharmaceuticals Europe.
- N‑nitroso‑duloxetine is a nitrosamine impurity that regulators say may raise cancer risk with long‑term exposure above safe limits and the FDA's interim acceptable intake for this impurity is 26.5 nanograms per day.
- Officials classified the action as Class II and report no known adverse events so far; clinicians advise patients to consult their prescriber for safe alternatives because abrupt stopping can cause withdrawal and relapse.
- This June recall follows similar nitrosamine detections in April 2026 and 2024, signaling a recurring manufacturing or supplier‑chain quality problem that could tighten supply of duloxetine for patients.