The Recall Desk
HighFDA (Drugs)·D-0095-2025·Announced 2024-12-11

Diltiazem Hydrochloride Extended-Release Capsules Recalled for Manufacturing Impurity

Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a manufacturing deviation with the presence of a nitrosamine impurity above recommended levels. No illnesses or injuries have been reported; therefore, this meets the criterion for a risk-of-harm product where injury has not yet been reported, resulting in a High severity score.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg due to a current Good Manufacturing Practice (cGMP) deviation.

The affected product contains N-nitroso-Desmethyl-Diltiazem impurity above the FDA-recommended interim limit. The recall involves the following lot numbers: 17222470, 17230680, and 17222547 (expiration 11/30/2024); 17230304 (expiration 12/31/2024); and 17230598 (expiration 02/2025). The product NDC is 68462-562-01.

The affected medication was distributed nationwide in the United States. This is classified as a Class II recall by the FDA.

The recalled product

Product
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Brand
DILTIAZEM HYDROCHLORIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug
Hazard
Affected units
25,584

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 (9)

  • Lot #: 17222470
  • 17230680
  • 17222547
  • Exp. Date 11/30/2024
  • 17230304
  • Exp. Date
  • 12/31/2024
  • 17230598
  • 02/2025.

UPCs (3)

  • 0368462562017
  • 0368462851012
  • 0368462850015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

Same brand · DILTIAZEM HYDROCHLORIDE

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

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Same hazard · nitrosamine impurity

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