Duloxetine D/R recalled over manufacturing violations

Recall date

March 7, 2025

Source

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

Official notice title

Direct Rx recalls Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 6191…

Recall number

D-0568-2025

FDA classification

Class II

Brand / firm

Direct Rx

Sold / distributed

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 D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,