Carvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit
Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles 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, 25 mg, supplied in 500-tablet cartons and available on prescription only, are being recalled. The product is manufactured by Glenmark Pharmaceuticals Ltd. in Pithampur, Madhya Pradesh, India. Affected lots are 17241213, 17241215 and 17241224, all with an expiry date of 06/2026. The recall covers 14,976 bottles 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 list above 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
- Glenmark Pharmaceuticals Inc., USA
- 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 (4)
- Lot #: 17241213
- 17241215
- 17241224
- Exp. Date 06/2026
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
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