Class IIReported 2025-04-16

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.

Recalled by Glenmark Pharmaceuticals Inc., USA

Reason for Recall

CGMP Deviations

Recall Number

D-0351-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-03-13

Reported

2025-04-16

Distribution

U.S. Nationwide

Code Info

Lot # 17230819, exp. date Mar-25

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.