NDC 68462-562

Diltiazem Hydrochloride 120 mg capsule, extended release

On the label: Glenmark Pharmaceuticals Inc., USA.

Where it's made

Recalls

• Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
  CGMP Deviations
  Lots: Lot # 17241067, exp. date May-26 17241628, exp. date Aug-26
• Nov 1, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
  cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
  Lots: Lot #s: 17222544, Exp. Date 11/30/2024 ; 17230784, Exp Date 03/31/2025; 17231080, Exp. Date 04/30/2025
• Nov 1, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
  cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
  Lots: Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025
• Nov 1, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
  cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
  Lots: Lot #: 17222470, 17230680, 17222547, Exp. Date 11/30/2024; 17230304, Exp. Date, 12/31/2024; 17230598, Exp. Date, 02/2025.
• Apr 17, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
  Failed Dissolution Specifications
  Lots: Lot #: 17221312, Exp. 5/31/2024
• Mar 26, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
  Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
  Lots: Lot #: 17230304, Exp. 12/31/2024.

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Diltiazem: every company that makes it

Form

capsule, extended release, oral

Strength

120 mg

Approval

ANDA ANDA212317

On the market since

Mar 22, 2021

Package NDCs

68462-562-01

Official label

DailyMed (National Library of Medicine), updated Jan 29, 2026

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