Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0316-2025

D-0316-2025 Class II Ongoing

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Recall Details

Product Type: Drugs
Report Date: April 16, 2025
Initiation Date: March 13, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

Propafenone Hydrochloride Extended-Release Capsules 325mg, 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# 68462-409-60

Reason for Recall

CGMP Deviations

Distribution Pattern

U.S. Nationwide

Code Information

Lot # 17230767, exp. date Mar-25

Other recalls by Glenmark Pharmaceuticals Inc., USA

D-0246-2026 Class II — Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards (December 30, 2025)
D-0199-2026 Class III — Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packag (November 21, 2025)
D-0222-2026 Class III — Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmac (November 18, 2025)
D-0662-2025 Class II — Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: (September 17, 2025)
D-0021-2026 Class II — Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Es (September 3, 2025)
D-0583-2025 Class II — Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufact (August 8, 2025)
D-0578-2025 Class II — Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl (August 7, 2025)
D-0579-2025 Class II — Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glen (August 7, 2025)
D-0577-2025 Class II — Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-16 (August 7, 2025)
D-0588-2025 Class II — Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by (August 6, 2025)