Carvedilol Tablets Recalled for N-Nitroso Impurity Above FDA Limits
Glenmark Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide because testing found an impurity (NNCI) at levels above FDA's recommended safety limit. The recall affects 14,976 bottles.
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: N-nitroso impurities are regulated as potential carcinogens. The source reports the manufacturing deviation and impurity levels without indicating any reported illnesses or injuries, fitting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets, USP, 25 mg, due to manufacturing quality deviations. Testing identified that the product contains N-Nitroso Carvedilol Impurity-1 (NNCI) at levels exceeding the FDA-recommended limit of 4.0 parts per million (ppm).
The recall encompasses 14,976 bottles distributed nationwide within the United States. The affected lot numbers are 17241213, 17241215, and 17241224, each with an expiration date of June 2026. The product is sold under NDC 68462-165-05. The medication is manufactured by Glenmark Pharmaceuticals Ltd. in India and distributed by Glenmark Pharmaceuticals Inc., USA.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- n-nitroso-impurity
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.
Related recalls
Same brand · CARVEDILOL
- HighCarvedilol Tablets Recalled for Manufacturing Impurity Exceeding FDA Limit
FDA (Drugs) · 2025-08-27
- HighCarvedilol Tablets Recalled Due to Nitrosamine Impurity Above Acceptable Levels
FDA (Drugs) · 2025-08-20
- HighCarvedilol tablets recalled nationwide for excess N-nitroso impurity
FDA (Drugs) · 2025-08-20
- HighCarvedilol tablets recalled nationwide due to nitrosamine impurity
FDA (Drugs) · 2025-08-20
- HighCarvedilol Tablets Recalled Due to Nitrosamine Impurity Contamination
FDA (Drugs) · 2025-08-20
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27