US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Nov 19, 2024 (2 years ago)

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

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

Recalling firm
Rising Pharma Holding, Inc.
NDC code
57237-019-30
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0107-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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