The Recall Desk
ModerateFDA (Drugs)·D-0342-2025·Announced 2025-04-16

Diltiazem Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and initiated by the firm.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall with no reported illnesses or injuries, and the hazard is a manufacturing-process deviation without evidence of actual product harm. Per the rubric, this qualifies as Moderate (score 2) rather than High, since there is no evidence of the deviation causing adverse health consequences.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottles (NDC# 68462-562-01) distributed nationwide. The recall was initiated on March 13, 2025, and classified by the FDA on April 8, 2025. The specific lots affected are Lot # 17241067 (expiration date May-26) and Lot # 17241628 (expiration date Aug-26).

The reason for recall is Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall initiated by the firm and communicated via letter to the FDA.

Diltiazem Hydrochloride is a prescription medication used to treat high blood pressure and angina. Patients currently taking this medication who have bottles from the affected lots should contact their healthcare provider or pharmacist for guidance. Consumers should not discontinue use of their medication without consulting a healthcare professional.

The recalled product

Product
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Brand
DILTIAZEM HYDROCHLORIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription / Cardiovascular
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot # 17241067
  • exp. date May-26 17241628
  • exp. date Aug-26

UPCs (3)

  • 0368462562017
  • 0368462851012
  • 0368462850015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 39 products in this recall →

Related recalls

Same brand · DILTIAZEM HYDROCHLORIDE

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

See all →

Same hazard · cgmp deviation

See all →