Duloxetine Delayed-Release Capsules USP recalled over manufacturing violations

Recall date

April 14, 2025

Source

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

Official notice title

Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe…

Recall number

D-0387-2025

FDA classification

Class II

Brand / firm

Breckenridge Pharmaceutical, Inc

Sold / distributed

US Nationwide.

Why it was recalled

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed 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, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10