Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Propafenone Hydrochloride Extended-Release Capsules USP Recalled by Glenmark Pharmaceuticals Inc., USA Due to CGMP Deviations

Date: March 13, 2025
Company: Glenmark Pharmaceuticals Inc., USA
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Glenmark Pharmaceuticals Inc., USA directly.

Affected Products

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.

Quantity: N/A

Why Was This Recalled?

CGMP Deviations

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Glenmark Pharmaceuticals Inc., USA

Glenmark Pharmaceuticals Inc., USA has 139 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report