[pending] CARVEDILOL (CARVEDILOL)
Pending LLM rewrite. Source: FDA_DRUG D-0448-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Drugs
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 19231450
- Exp Mar-25
- 19233345
- Exp Jul-25
- Lot 19234275
- Exp Sep-25
- Lot 19240280
- Exp DEC-25 [500-Count Bottles] Lot 19231450
- 19231464
- 19231471
- 19231493
- 19232083
- 19232103 Exp Apr-25
- 19232658
- Exp Jun-25
- Lot 19233328
- 19233343
- 19233344
- Lots 19234843
- 19235039
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CARVEDILOL
- HighPrescription Carvedilol recalled for manufacturing impurity exceeding FDA specifications
FDA (Drugs) · 2025-02-12
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- LowCarvedilol Tablets Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2021-12-01
- SevereCarvedilol Tablets Recalled for Foreign Paroxetine Tablets
FDA (Drugs) · 2021-08-25
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