Duloxetine Delayed-Release Capsules recalled over manufacturing violations

Recall date

February 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.…

Recall number

D-0269-2025

FDA classification

Class II

Brand / firm

Breckenridge Pharmaceutical, Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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