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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 #: T05693, Exp. Date 03/2026
Where it was soldProduct was distributed nationwide within the United States.
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: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

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 byMajor Pharmaceuticals
Brand nameCARVEDILOL
Generic nameCARVEDILOL
Active ingredient(s)CARVEDILOL
Distributed by / forMajor Pharmaceuticals, Indianapolis, IN, 46268, USA
NDC0904-7307-61
Show the full FDA record
Full product labelCarvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
Recalling firmThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
DistributionProduct was distributed nationwide within the United States.
Quantity26,628 cartons
Recall initiated2025-08-20
Report date2025-08-27
Recall completed—
Recall numberD-0594-2025
ClassificationClass II
FDA statusOngoing
Origin on fileLa Vergne TN 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.