Overview
- Breckenridge Pharmaceutical voluntarily pulled nearly 370,000 bottles of duloxetine distributed nationwide, covering 360,000 bottles of 60 mg capsules and 14,000 bottles of 30 mg capsules across specific lot numbers.
- FDA laboratory testing found levels of N‑nitroso‑duloxetine, a nitrosamine impurity, that exceed the agency's interim acceptable intake limits and the recall was classified as Class II.
- The recalled product was manufactured by Towa Pharmaceuticals Europe in Spain and sold in the U.S. by Breckenridge, and the distributor reports no known adverse events tied to the affected lots.
- Patients are advised not to stop duloxetine abruptly and should contact their prescribers to discuss safe alternatives or tapering plans because sudden cessation can cause withdrawal‑like symptoms.
- Health officials note nitrosamines occur in food and the environment but raise cancer risk with prolonged exposure above limits, and repeated duloxetine recalls underline ongoing manufacturing and supply‑chain quality concerns.