[pending] CARVEDILOL (CARVEDILOL)
Pending LLM rewrite. Source: FDA_DRUG D-0449-2025.
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 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.
Related recalls
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- 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
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- SevereCarvedilol Tablets Recalled for Foreign Paroxetine Tablets
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