FDA Recall D-0315-2025

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 427 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-408-60

Lot / code: Lot # 17230819, exp. date Mar-25

Quantity: N/A

Reason for recall

CGMP Deviations

Recall record

Recall number: D-0315-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2025-03-13
Classified by FDA Center: 2025-04-08
FDA published: 2025-04-16
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): PROPAFENONE HYDROCHLORIDE
Generic name(s): PROPAFENONE HYDROCHLORIDE
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-408, 68462-409, 68462-410
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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