The Recall Desk
HighFDA (Drugs)·D-0096-2025·Announced 2024-12-11

Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity

Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.

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 defect that resulted in a potentially harmful impurity above the FDA's interim safety limit. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario. Per the severity rubric, risk-of-harm products with no reported injury are classified as High (3).

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules 60 mg (Lot #17222544, expiration 11/30/2024) distributed nationwide. The recall affects approximately 5,232 bottles.

The recall was initiated due to a manufacturing quality deviation (cGMP violation): the presence of the impurity N-nitroso-Desmethyl-Diltiazem above the FDA's recommended interim limit. This impurity resulted from manufacturing conditions that did not meet current Good Manufacturing Practice standards.

Diltiazem is a prescription medication used to treat certain heart conditions. All patients who received this medication from the recalled lot may be affected.

Consumers who are currently taking this medication should contact their pharmacist or healthcare provider before making any changes to their treatment regimen. Do not stop taking the medication without medical guidance. Patients may ask their pharmacist about alternative sources of diltiazem that are not affected by this recall.

The recalled product

Product
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Brand
DILTIAZEM HYDROCHLORIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription Medication
Hazard
Affected units
5,232

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 (2)

  • Lot #: 17222544
  • Exp 11/30/2024.

UPCs (3)

  • 0316714555010
  • 0316714553016
  • 0316714554013

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 · impurity

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