Diltiazem Hydrochloride Capsule, Extended Release
FDA Recall NDC 68462-562
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Diltiazem Hydrochloride (NDC 68462-562). A significant event, classified as Class II, was initiated on Mar 13, 2025 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "CGMP Deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations
Mar 13, 2025
Apr 16, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96474
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# 17241067, exp. date May-26 17241628, exp. date Aug-26
Affected Packages Involved in this Recall
68462-850-01Product
68462-851-01Product
68462-562-01Product
Class II Ongoing
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Nov 01, 2024
Dec 11, 2024
34848 bottles
Recall Profile & Regulatory Data
Event ID
95660
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.
Batch or Lot Expiration Information
Lot# s: 17222544, Exp. Date 11/30/2024 ; 17230784, Exp Date 03/31/2025; 17231080, Exp. Date 04/30/2025
Affected Packages Involved in this Recall
68462-850-01Product
68462-851-01Product
68462-562-01Product
Class II Ongoing
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Nov 01, 2024
Dec 11, 2024
12,864 bottles
Recall Profile & Regulatory Data
Event ID
95660
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.
Batch or Lot Expiration Information
Lot# s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025
Affected Packages Involved in this Recall
68462-850-01Product
68462-851-01Product
68462-562-01Product
Class II Ongoing
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Nov 01, 2024
Dec 11, 2024
25584 bottles
Recall Profile & Regulatory Data
Event ID
95660
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# : 17222470, 17230680, 17222547, Exp. Date 11/30/2024; 17230304, Exp. Date, 12/31/2024; 17230598, Exp. Date, 02/2025.
Affected Packages Involved in this Recall
68462-850-01Product
68462-851-01Product
68462-562-01Product
Class II Ongoing
Failed Dissolution Specifications
Apr 17, 2024
May 01, 2024
3,264 bottles
Recall Profile & Regulatory Data
Event ID
94440
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01.
Batch or Lot Expiration Information
Lot# : 17221312, Exp. 5/31/2024
Affected Packages Involved in this Recall
68462-850-01Product
68462-851-01Product
68462-562-01Product
Class II Ongoing
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Mar 26, 2024
Apr 10, 2024
6,528 bottles
Recall Profile & Regulatory Data
Event ID
94280
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
Batch or Lot Expiration Information
Lot# : 17230304, Exp. 12/31/2024.
Affected Packages Involved in this Recall
68462-850-01Product
68462-851-01Product
68462-562-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
