Carvedilol tablets recalled nationwide for excess N-nitroso impurity
Glenmark Pharmaceuticals is recalling 17,496 bottles of Carvedilol 12.5 mg tablets nationwide due to manufacturing defects. Tests found N-nitroso impurity levels above FDA limits.
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: This FDA Class II recall involves a manufacturing defect that resulted in N-nitroso impurities exceeding the FDA-recommended safety limit. With no reported illnesses, it qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol (CARVEDILOL) Tablets, USP, 12.5 mg. The recall affects 17,496 bottles distributed nationwide. The affected lot numbers are 17241257, 17241258, and 17241279, with expiration dates of June 2026.
The recall is due to current Good Manufacturing Practice (CGMP) deviations. During testing, the drug was found to contain N-Nitroso Carvedilol Impurity-1 (NNCI) at levels exceeding the FDA-recommended limit of 4.0 parts per million.
Patients currently taking affected Carvedilol tablets should contact their pharmacist or healthcare provider immediately. Do not discontinue the medication without consulting their healthcare provider. Affected consumers should return the recalled product to their pharmacy for proper disposal or replacement.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- n-nitroso-impurity
- manufacturing-defect
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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