The Recall Desk
SevereFDA (Drugs)·D-0448-2025·Announced 2025-06-04

Carvedilol Tablets Recalled Due to N-Nitroso Impurity

Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 3.125mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a prescription drug with a manufacturing defect resulting in an impurity above acceptable limits. Class II recalls with manufacturing deviations and potential for patient harm are classified as Severe per the rubric.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 3.125mg in both 100-count bottles (NDC 68462-162-01) and 500-count bottles (NDC 68462-162-05) due to Current Good Manufacturing Practice (CGMP) deviations. The recall is prompted by the detection of N-Nitroso Carvedilol I impurity at levels above the recommended acceptable intake limit.

The affected product was distributed nationwide. Specific lot numbers and expiration dates have been identified by the manufacturer and are available in the detailed recall information. Consumers taking this medication should not discontinue use without consulting their healthcare provider, as stopping carvedilol abruptly may pose health risks.

Patients who have received affected lots should contact their pharmacist or healthcare provider for guidance on obtaining an alternative supply of carvedilol or a therapeutic substitute. The FDA and manufacturer continue to monitor this situation.

The recalled product

Product
CARVEDILOL (CARVEDILOL)
Brand
CARVEDILOL
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription Cardiovascular
Hazard

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 (20)

  • [100-Count Bottles] Lot 19231450
  • Exp Mar-25
  • 19233345
  • Exp Jul-25
  • Lot 19234275
  • Exp Sep-25
  • Lot 19240280
  • Exp DEC-25 [500-Count Bottles] Lot 19231450
  • 19231464
  • 19231471
  • 19231493
  • 19232083
  • 19232103 Exp Apr-25
  • 19232658
  • Exp Jun-25
  • Lot 19233328
  • 19233343
  • 19233344
  • Lots 19234843
  • 19235039

UPCs (4)

  • 0368462162019
  • 0368462163016
  • 0368462164013
  • 0368462165010

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same brand · CARVEDILOL

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

See all →

Same hazard · n nitroso impurity

See all →