Recall D-0216-2026

US Class II Ongoing · initiated 2025-11-24

Recalling firm

Breckenridge Pharmaceutical, Inc., NJ

Product

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

Reason for recall

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

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