The Recall Desk
HighFDA (Drugs)·D-0093-2025·Announced 2024-12-11

Diltiazem Hydrochloride Capsules Recalled Due to Manufacturing Impurity

Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride Extended-Release Capsules (60 mg) due to presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA limits. Approximately 34,848 bottles nationwide are affected.

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 detection of an impurity above the FDA recommended limit, representing a risk of harm from a known genotoxic compound. No illnesses or injuries have been reported, making this a preventive manufacturing recall that fits the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg (Twice-a-Day Dosage) across the United States. The recall affects approximately 34,848 bottles with the following lot numbers: 17222544 (expiration 11/30/2024), 17230784 (expiration 03/31/2025), and 17231080 (expiration 04/30/2025).

The recall was initiated due to cGMP deviations related to the presence of N-nitroso-Desmethyl-Diltiazem impurity found at levels exceeding the FDA's recommended interim limit. This impurity was detected during manufacturing quality control.

Patients taking a product from one of the affected lots should contact their healthcare provider or pharmacist for guidance. Do not abruptly stop taking this medication without consulting a healthcare professional. Affected bottles may be returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Brand
DILTIAZEM HYDROCHLORIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug
Hazard
Affected units
34,848

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 (6)

  • Lot #s: 17222544
  • Exp. Date 11/30/2024
  • 17230784
  • Exp Date 03/31/2025
  • 17231080
  • Exp. Date 04/30/2025

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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