The Recall Desk
HighFDA (Drugs)·D-0216-2025·Announced 2025-02-12

Carvedilol Tablets Recalled for Carcinogenic N-Nitroso Impurity Manufacturing Defect

Glenmark Pharmaceuticals is recalling carvedilol tablets nationwide due to N-nitroso carvedilol I (NNCI-I), a carcinogenic impurity found in certain lots. The impurity exceeds FDA safety limits.

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 with N-nitroso carvedilol I impurity, a known carcinogenic substance exceeding FDA safe limits, but with no reported illnesses or injuries. Classified as risk-of-harm where injury has not yet been reported per the severity rubric.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Carvedilol tablets, USP, 12.5 mg distributed nationwide. The recall includes 500-tablet bottles (NDC 68462-164-05) and 100-tablet bottles (NDC 68462-164-01) with specific lot numbers and expiration dates listed in the FDA recall notice.

This recall stems from a manufacturing defect identified as a Current Good Manufacturing Practice (CGMP) deviation. Testing found N-Nitroso Carvedilol I (NNCI-I) impurity in affected lots at levels exceeding FDA-recommended limits.

Patients taking carvedilol should check the lot number and expiration date on their medication bottle. Patients should not stop their medication without first consulting their healthcare provider. Those with affected lots should contact their pharmacy or healthcare provider for replacement options.

More information about affected lot numbers and expiration dates is available on the FDA website and from Glenmark Pharmaceuticals.

The recalled product

Product
CARVEDILOL (CARVEDILOL)
Brand
CARVEDILOL
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug
Hazard
  • n-nitroso-impurity

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)

  • Lot numbers: a) 17230658
  • Exp.: 02/2025
  • 17230814
  • 17230822
  • Exp.: 03/2025
  • 17231004
  • 17231009
  • 17231022
  • Exp.: 04/2025
  • 17231393
  • 17231392
  • Exp.: 05/2025
  • 17231538
  • 17231541
  • 17231542
  • Exp.: 06/2025
  • 17231710
  • 17231718
  • 17231721
  • 17231722

UPCs (4)

  • 0368462162019
  • 0368462163016
  • 0368462164013
  • 0368462165010

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · CARVEDILOL

Same category