Class IITerminated

DULoxetine DR USP recall

FDA recall D-0163-2025 · initiated Dec 4, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

Details

Product: DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Recalling company: PD-Rx Pharmaceuticals, Inc.
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Distributed within US: FL, MS, WI
Initiated: Dec 4, 2024
FDA report date: Jan 1, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0163-2025 ↗

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