The Recall Desk
HighFDA (Drugs)·D-0577-2025·Announced 2025-08-20

Carvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit

Glenmark Carvedilol Tablets USP, 3.125 mg, in 100- and 500-count bottles are recalled nationwide because N-Nitroso Carvedilol I impurity exceeded the current Acceptable Intake level. 44,328 bottles 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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a nitrosamine above the Acceptable Intake level is a potential harm and no injuries are reported.

Plain-English summary

Carvedilol Tablets, USP, 3.125 mg, are being recalled in 500-count bottles under NDC 68462-162-05 and 100-count bottles under NDC 68462-162-01. The prescription-only product is manufactured by Glenmark Pharmaceuticals Ltd in Colvale-Bardez, Goa, India. Affected lots are 19242274, 19242275 and 19242272 for the 500-count presentation, and 19242272 for the 100-count presentation with an expiry of 5/31/2026. The recall covers 44,328 bottles distributed nationwide.

The recall follows current good manufacturing practice deviations: the presence of a nitrosamine, N-Nitroso Carvedilol I impurity, above the current Acceptable Intake level. The FDA classified the action as Class II.

Patients should check the lot number on their bottle against the list above and should not stop taking a prescribed medicine without speaking to their pharmacist or prescriber about a replacement supply.

The recalled product

Product
CARVEDILOL (CARVEDILOL)
Brand
CARVEDILOL
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Cardiovascular
Hazard
Affected units
44,328

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#: a)19242274
  • 19242275
  • 19242272
  • Exp: 5/31/20
  • b) 19242272
  • Exp: 5/31/2026

UPCs (4)

  • 0368462162019
  • 0368462163016
  • 0368462164013
  • 0368462165010

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 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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