Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit
Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles 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: Risk-of-harm product: a nitrosamine impurity measured above the FDA's named 4.0 ppm limit, with no injury reported in the source.
Plain-English summary
Carvedilol Tablets, USP, 12.5 mg, 500 tablets per carton, prescription only, manufactured by Glenmark Pharmaceuticals Ltd. of Pithampur, Madhya Pradesh, India for Glenmark Pharmaceuticals, is being recalled. The action covers 17,496 bottles.
The stated reason is CGMP deviations: results for the N-Nitroso Carvedilol Impurity-1 impurity were observed to be above the FDA-recommended limit of not more than 4.0 ppm. The FDA classified the action as Class II.
Affected lots are 17241257, 17241258 and 17241279, expiring 06/2026. Distribution was nationwide within the USA.
Patients holding affected lots should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by Glenmark.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Oral tablet
- Hazard
- nitrosamine
- n-nitroso-carvedilol
- impurity-limit
- cgmp-deviation
- 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 #: 17241257
- 17241258
- 17241279
- Exp. Date 06/2026
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
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