Carvedilol Tablets Recalled for N-Nitroso Impurity Above Acceptable Limits
Glenmark Pharmaceuticals is recalling 18,696 bottles of Carvedilol 25mg tablets nationwide due to manufacturing violations and N-nitroso impurity above acceptable intake limits. Affected lots are 19231107, 19231114, 19231152, and 19234866.
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: FDA Class II recall with no reported illnesses or injuries. The hazard—N-nitroso carvedilol I impurity above the acceptable intake limit—represents a risk of harm, but no actual adverse effects have been reported. This satisfies the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Glenmark Pharmaceuticals Inc. is recalling 18,696 bottles of Carvedilol tablets (25mg strength) distributed nationwide. The recall results from current Good Manufacturing Practice violations and the presence of N-nitroso carvedilol I impurity at levels exceeding the FDA's recommended acceptable intake limit.
The recall affects four manufacturing lots: 19231107, 19231114, and 19231152 with a February 2025 expiration date, and lot 19234866 with a January 2026 expiration date. Each affected bottle contains 500 tablets.
This is an FDA Class II recall. The impurity levels and associated manufacturing deviations triggered the recall action.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- 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 (7)
- Lot
- expiry: Lots 19231107
- 19231114
- 19231152
- Exp Feb-25
- Lot 19234866
- Exp Jan-26
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
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