Duloxetine DR Capsules USP 60 mg recalled over manufacturing violations

Recall date

November 19, 2024

Source

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

Official notice title

Rising Pharma Holding, Inc. recalls Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 5…

Recall number

D-0107-2025

FDA classification

Class II

Brand / firm

Rising Pharma Holding, Inc.

Sold / distributed

Nationwide.

Why it was recalled

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above 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 DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ