US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Mar 13, 2025 (1 years ago)

Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations

What was recalled

Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-562-01

Recalling firm
Glenmark Pharmaceuticals Inc., USA
NDC code
68462-562-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0342-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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