Prescription Carvedilol recalled for manufacturing impurity exceeding FDA specifications
Glenmark Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide due to a manufacturing quality issue with impurity levels exceeding FDA recommended limits. Multiple lot numbers and expiration dates from February 2025 through February 2026 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: This FDA Class II recall involves manufacturing quality deviation with N-Nitroso Carvedilol I impurity exceeding FDA recommended limits. Per the severity rubric, this is a risk-of-harm scenario, placing it in severity 3 (High).
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol 25 mg tablets (NDC 68462-165-05 and 68462-165-01) due to a manufacturing quality deviation identified during testing. The N-Nitroso Carvedilol I (NNCI-I) impurity levels in affected batches exceed the FDA recommended limit.
The recall affects multiple lot numbers that were distributed nationwide in the United States. The affected products have expiration dates from February 2025 through February 2026. This is classified as a Class II recall by the FDA.
Patients currently using Carvedilol tablets should contact their pharmacist or healthcare provider to verify whether their medication is included in this recall. The FDA has published specific lot numbers and expiration dates to help identify affected products.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- n-nitroso-impurity
- cgmp-deviation
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 (20)
- Lot numbers: a) 17230500
- 17230509
- 17230526
- 17230546
- 17230551
- 17230603
- 17230628
- 17230642
- 17230645
- 17230681
- Exp.:02/2025
- 17230829
- 17230832
- 17230854
- 17230864
- 17230874
- 17230876
- 17230889
- 17230894
- Exp.: 03/2025
UPCs (5)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
- 202517231315
Distribution
Distributed nationwide across the United States.
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