Carvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit
Glenmark Pharmaceuticals is recalling Carvedilol Tablets USP 25 mg nationwide due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from CGMP deviations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a potential health hazard (N-Nitroso impurity, a known carcinogen class) without reported illnesses. The hazard is a manufacturing deviation leading to a documented impurity above acceptable limits, which meets the Severe threshold for Class II recalls with identified risk.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 25 mg, 500-Count bottles (NDC 68462-165-05) manufactured for distribution nationwide. The recall is due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, which resulted from Current Good Manufacturing Practice (CGMP) deviations.
Affected lots include Lots 19231107, 19231114, and 19231152 with expiration date February 2025, and Lot 19234866 with expiration date January 2026. A total of 18,696 bottles have been distributed.
Consumers who have this medication should contact their pharmacist or healthcare provider for guidance. Do not stop taking the medication without consulting a healthcare professional, as abrupt discontinuation may be harmful. Patients should return unused product to their pharmacy.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Medication
- Hazard
- nitrosamine-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 (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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