Duloxetine Delayed-Release Capsules recalled over manufacturing violations

Recall date

July 25, 2025

Source

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

Official notice title

Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutic…

Recall number

D-0580-2025

FDA classification

Class II

Brand / firm

Breckenridge Pharmaceutical, Inc.

Sold / distributed

NJ, AZ, IN

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, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10