US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Mar 13, 2025 (1 years ago)

Propafenone Hydrochloride Extended-Release Capsules

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

Why it was recalled

CGMP Deviations

What was recalled

Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01

Recalling firm
Glenmark Pharmaceuticals Inc., USA
NDC code
16714-826-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0352-2025

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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