Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Agency: FDA
Recall date: 2026-06-04
Recalling firm: Breckenridge Pharmaceutical, Inc

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Severity: Class II
Distribution: Nationwide within the United States