Carvedilol 12.5 mg tablets recalled over nitrosamine above acceptable intake level
Glenmark Carvedilol Tablets USP, 12.5 mg, lot 19243202, are recalled nationwide because N-Nitroso Carvedilol I impurity was found above the current Acceptable Intake level. 6,432 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; a nitrosamine above the Acceptable Intake level is a potential harm and no injuries are reported.
Plain-English summary
Carvedilol Tablets, USP, 12.5 mg, in 500-count bottles and available on prescription only, NDC 68462-164-05, are being recalled. The product is manufactured by Glenmark Pharmaceuticals Ltd in Colvale-Bardez, Goa, India for Glenmark Pharmaceuticals, Inc. of Mahwah, New Jersey. The affected product is lot 19243202 with an expiry of 7/31/2026, and the recall covers 6,432 bottles distributed nationwide.
The recall follows current good manufacturing practice deviations: the presence of a nitrosamine, N-Nitroso Carvedilol I impurity, above the current Acceptable Intake level. The FDA classified the action as Class II.
Patients should check the lot number on their bottle 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
- 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 (2)
- Lot#:19243202
- Exp: 7/31/2026.
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
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