Duloxetine DR Capsules USP 60 mg recalled over manufacturing violations

Recall date

December 30, 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) and b) 1000 count (NDC 57237-019-99) bottles; Distribu…

Recall number

D-0190-2025

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) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ