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

Glenmark recalls Carvedilol tablets for genotoxic impurity above limits

Glenmark Pharmaceuticals is recalling certain lots of Carvedilol 3.125mg tablets nationwide due to N-Nitroso Carvedilol I, a genotoxic impurity, exceeding FDA's acceptable intake limit.

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: FDA Class II recall due to genotoxic impurity (N-Nitroso Carvedilol I) exceeding recommended acceptable intake limits, caused by CGMP deviations. No illnesses or injuries reported, classifying this as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Carvedilol 3.125mg tablets distributed nationwide. The recall is due to the presence of N-Nitroso Carvedilol I, a genotoxic impurity, above the FDA's recommended acceptable intake limit. This impurity resulted from current good manufacturing practice (CGMP) deviations during manufacturing.

Affected products include Carvedilol 3.125mg tablets in 100-count bottles (NDC 68462-162-01) and 500-count bottles (NDC 68462-162-05). Recalled lot numbers for 100-count bottles are: Lot 19231450 (March 2025), Lot 19233345 (July 2025), Lot 19234275 (September 2025), and Lot 19240280 (December 2025). Recalled lot numbers for 500-count bottles are: Lots 19231450, 19231464, 19231471, 19231493 (March 2025), Lots 19232083, 19232103 (April 2025), Lot 19232658 (June 2025), Lots 19233328, 19233343, 19233344, 19233345 (July 2025), Lot 19234275 (September 2025), Lots 19234843, 19235039 (November 2025), and Lots 19240280, 19240296 (December 2025). Approximately 59,952 bottles of 100-count product and 155,976 bottles of 500-count product were distributed nationwide.

Patients taking Carvedilol should not stop taking their medication without consulting their healthcare provider, as Carvedilol is used to treat heart failure and high blood pressure. Patients who have any of the recalled lot numbers should contact their pharmacy or healthcare provider to verify whether their medication is affected and to discuss alternative sources. Adverse events should be reported to the FDA's MedWatch program.

The recalled product

Product
CARVEDILOL (CARVEDILOL)
Brand
CARVEDILOL
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug
Hazard
  • nitrosamine-impurity
  • cgmp-deviation

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.

Related recalls

Same brand · CARVEDILOL

Same category