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Class II · ModerateActive recall

Carvedilol

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430
Brand nameCARVEDILOL
Generic nameCARVEDILOL
Active ingredient(s)CARVEDILOL
Distributed by / forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430
NDC68462-165-05
Show the full FDA record
Full product labelCarvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.
Recalling firmGlenmark Pharmaceuticals Inc., USA
DistributionU.S. Nationwide
Quantity18,696 bottles
Recall initiated2025-02-28
Report date2025-06-04
Recall completed—
Recall numberD-0451-2025
ClassificationClass II
FDA statusOngoing
Origin on fileMahwah NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.