The Recall Desk
HighFDA (Drugs)·D-0094-2025·Announced 2024-12-11

Diltiazem Hydrochloride Capsules Recalled Due to N-Nitroso Impurity Above Limits

Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.

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: FDA Class II classification for N-nitroso impurity above the regulatory interim limit. This represents a risk-of-harm product with no reported illness, fitting Score 3 per the rubric.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg (Rx Only) in bottles of 100 capsules. The affected product was manufactured in India and distributed nationwide in the United States. The recall affects 12,864 bottles with the following lot numbers and expiration dates: Lot #17222452 (Expiration 11/30/2024) and Lot #17230607 (Expiration 02/28/2025).

The recall was initiated due to current good manufacturing practice (cGMP) deviations. Specifically, the product contains N-nitroso-desmethyl-diltiazem impurity at levels above the FDA's recommended interim limit.

Patients currently taking this product should consult with their pharmacist or healthcare provider before stopping use. Consumers with affected lot numbers should not discard their medication without professional guidance. Pharmacists should quarantine affected product and contact customers who have received bottles from the affected lots.

The recalled product

Product
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Brand
DILTIAZEM HYDROCHLORIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug
Hazard
Affected units
12,864

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 (5)

  • Lot #s 17222452
  • Exp. Date
  • 11/30/2024
  • 17230607
  • Exp. Date 02/28/2025

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 · n nitroso impurity

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