Major Pharmaceuticals carvedilol tablets recalled over nitrosamine impurity above FDA limit
Carvedilol Tablets USP, 12.5 mg, packaged by Major Pharmaceuticals, lot T05693, are recalled nationwide because N-Nitroso Carvedilol Impurity-1 exceeded the FDA-recommended 4.0 ppm limit. 26,628 cartons 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; an impurity above the FDA-recommended limit is a potential harm and no injuries are reported.
Plain-English summary
Carvedilol Tablets USP, 12.5 mg, in 100-tablet (10x10) cartons and available on prescription only, NDC 0904-7307-61, are being recalled. The product is packaged and distributed by Major Pharmaceuticals of Indianapolis, Indiana. The affected product is lot T05693 with an expiry of 03/2026, and the recall covers 26,628 cartons distributed nationwide.
The recall follows current good manufacturing practice deviations: results for the N-Nitroso Carvedilol Impurity-1 (NNCI) impurity were observed above the FDA-recommended limit of not more than 4.0 parts per million. The FDA classified the action as Class II.
Patients should check the lot number on their carton against the recall 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
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug — Cardiovascular
- Hazard
- nitrosamine-impurity
- cgmp-deviation
- prescription-drug
- class-ii
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 (2)
- Lot #: T05693
- Exp. Date 03/2026
Distribution
Distributed nationwide across the United States.
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