The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0097-2025·Announced 2024-12-11

Diltiazem extended-release capsules recalled for manufacturing impurity

Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA Class II pharmaceutical recall involves the presence of an impurity above FDA regulatory limits in a cardiac medication. The manufacturing defect exceeding regulatory thresholds meets criteria for a risk-of-harm product, warranting High severity despite no reported illnesses or injuries to date.

Plain-English summary

Glenmark Pharmaceuticals Inc. is recalling 4,704 bottles of Diltiazem Hydrochloride Extended-Release Capsules 90mg due to a cGMP (current Good Manufacturing Practice) deviation. The recall was initiated because of the presence of N-nitroso-Desmethyl-Diltiazem impurity at levels above FDA recommended interim limits.

The affected product includes two lot numbers: 17222452 (expiration 11/30/2024) and 17230607 (expiration 02/28/2025). The capsules were distributed nationwide in the United States.

Diltiazem is a prescription medication used to treat high blood pressure and certain heart conditions. Consumers who are taking this medication should not discontinue use without consulting their healthcare provider. Anyone with bottles matching the affected lot numbers should contact their pharmacy for a refund or replacement.

The recalled product

Product
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Brand
DILTIAZEM HYDROCHLORIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription Medication
Hazard
Affected units
4,704

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 (4)

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

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 →

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