Class IITerminated

Duloxetine Delayed-Release Capsules USP recall

FDA recall D-0212-2025 · initiated Jan 13, 2025

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

Why it was recalled

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Details

Product: Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Recalling company: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: Jan 13, 2025
FDA report date: Feb 5, 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-0212-2025 ↗

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