Carvedilol Tablets Recalled Due to Nitrosamine Impurity Contamination
Glenmark Pharmaceuticals is recalling 4,800 bottles of Carvedilol 25 mg tablets nationwide due to the presence of N-Nitroso Carvedilol I impurity above FDA-acceptable intake levels. The manufacturing deviation was identified during quality testing.
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 is an FDA Class II recall due to manufacturing contamination with a nitrosamine impurity above acceptable intake levels. No illnesses or injuries have been reported, and the hazard is theoretical. Per the rubric, Class II recalls without reported harm receive a score of 3.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets, USP, 25 mg nationwide. The affected product includes 500-count bottles (NDC 68462-165-05) from Lot #19243104, which expires July 31, 2026. Approximately 4,800 bottles are affected.
The recall is being conducted due to a Current Good Manufacturing Practice (CGMP) deviation. Testing identified the presence of N-Nitroso Carvedilol I, a nitrosamine impurity, at levels above the FDA's current Acceptable Intake Level.
Patients currently taking Carvedilol from the affected lot should contact their healthcare provider or pharmacist for guidance. Do not discontinue this medication without consulting a healthcare provider. Healthcare providers and pharmacists should check their inventory for the affected lot number and quarantine any affected product.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- nitrosamine
- manufacturing-contamination
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#:19243104
- Expires: 7/31/2026.
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
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