The Recall Desk
SevereFDA (Drugs)·D-0449-2025·Announced 2025-06-04

Carvedilol Tablets 6.25 mg Recalled for N-Nitroso Impurity

Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg 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 drug recall with identified manufacturing deviations (CGMP) and presence of a nitrosamine impurity (N-Nitroso Carvedilol I) above acceptable intake limits, meeting the criterion for Severe classification.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg in 100-count bottles (NDC 68462-163-01) and 500-count bottles (NDC 68462-163-05). The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations and the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit.

Affected lot numbers and expiration dates for 100-count bottles include: Lot 19231618 (Mar-25), 19232064 (Apr-25), 19232324 (May-25), 19233369 (Jul-25), 19234162 (Sep-25), and 19240543 (Jan-26). Affected lot numbers for 500-count bottles include: Lots 19231174, 19231199, 19231164 (Feb-25); 19231517, 19231527, 19231566, 19231568, 19231595, 19231618, 19231634, 19231638, 19231448 (Mar-25); 19232043, 19232051, 19232064 (Apr-25); 19232322, 19232324, 19232365, 19232380, 19232389 (May-25); 19232736, 19232743, 19232746, 19232756, 19232757 (Jun-25); 19233369, 19233371, 19233405, 19233416 (Jul-25); 19234162, 19234183, 19234192, 19234204, 19234223, 19234243, 19234263, 19234165, 19234242 (Sep-25); 19234743, 19234774, 19234993 (Nov-25); 19240223, 19240203, 19240211, 19240214, 19240247, 19240249, 19240272, 19240319 (Dec-25); and 19240543 (Jan-26). The affected product has been distributed U.S. nationwide.

Patients taking the affected medication should consult their healthcare provider before stopping the medication or for guidance on obtaining a replacement. Healthcare providers and pharmacists should stop dispensing affected lots immediately.

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 19231618
  • exp Mar-25
  • 19232064
  • exp Apr-25
  • 19232324
  • May-25
  • 19233369
  • Exp Jul-25
  • Lot 19234162
  • Exp Sep-25
  • Lot 19240543
  • Exp Jan-26 [500-Count Bottles] Lots 19231174
  • 19231199
  • 19231164
  • Exp Feb-25
  • 19231517
  • 19231527
  • 19231566
  • 19231568
  • 19231595

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

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Same hazard · nitrosamine impurity

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