Prescription Drug Recall: Carvedilol Tablets Due to Manufacturing Impurity
Glenmark Pharmaceuticals recalls Carvedilol 6.25 mg tablets nationwide due to N-Nitroso Carvedilol I impurity above acceptable limits from manufacturing process deviations. No illnesses have been reported.
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 confirmed chemical impurity (N-Nitroso Carvedilol I) above acceptable limits in a prescription cardiac medication. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product without reported injury, meeting the criteria for High severity.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg nationwide. The affected products are 100-count bottles (NDC 68462-163-01) and 500-count bottles (NDC 68462-163-05). A total of 90,000 100-count bottles and 324,288 500-count bottles are included in this recall.
The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. Testing identified the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit in affected lots.
Patients taking affected lots should not stop taking their medication without consulting their healthcare provider, as Carvedilol is an important heart medication. Consumers with affected product should contact their pharmacy or healthcare provider for guidance. Specific affected lot numbers and expiration dates range from February 2025 through January 2026.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- manufacturing-defect
- chemical-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 (20)
- [100-Count Bottles] Lot 19231618
- exp Mar-25
- 19232064
- exp Apr-25
- 19232324
- May-25
- 19233369
- Exp Jul-25
- Lot 19234162
- Exp Sep-25
- Lot 19240543
- Exp Jan-26 [500-Count Bottles] Lots 19231174
- 19231199
- 19231164
- Exp Feb-25
- 19231517
- 19231527
- 19231566
- 19231568
- 19231595
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
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