FDA recall D-0351-2025

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.

Reason for recall

CGMP Deviations

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-03-13
Report date: 2025-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0351-2025