Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.

Recall Number: D-0095-2025

Firm: Glenmark Pharmaceuticals Inc., USA

Classification: Class II

Status: Ongoing

Report Date: 20241211

Initiation Date: 20241101

Termination Date:

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.