Carvedilol Tablets Recalled Due to Nitrosamine Impurity Above Acceptable Levels
Glenmark Pharmaceuticals is recalling Carvedilol 12.5 mg tablets (Lot #19243202, expires 7/31/2026) due to N-Nitroso Carvedilol I nitrosamine impurity exceeding FDA acceptable intake levels. The recall affects 6,432 bottles distributed nationwide.
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 a nitrosamine impurity exceeding the Acceptable Intake Level, representing a risk-of-harm product. However, no illnesses, injuries, or deaths have been reported, placing this in the High category rather than Severe per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets, USP, 12.5 mg, in 500-count bottles. The recall affects 6,432 bottles with Lot #19243202 (expiration date 7/31/2026) distributed nationwide throughout the United States. The NDC number is 68462-164-05.
The recall was initiated due to Current Good Manufacturing Practices (cGMP) deviations. An impurity identified as N-Nitroso Carvedilol I, a nitrosamine compound, was detected during manufacturing at levels above the FDA's current Acceptable Intake Level.
Carvedilol is a prescription beta-blocker and alpha-blocker used to treat high blood pressure and heart failure. Consumers taking this medication should contact their healthcare provider or pharmacist immediately to confirm whether they have received an affected bottle.
Consumers should not stop taking their medication without consulting their doctor, as abrupt discontinuation may be harmful. Healthcare providers and pharmacies can help identify affected prescriptions and arrange for alternative medication as needed.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- nitrosamine
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#:19243202
- Exp: 7/31/2026.
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
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