[pending] CARVEDILOL (CARVEDILOL)
Pending LLM rewrite. Source: FDA_DRUG D-0588-2025.
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: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
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 (4)
- Lot #: 17241213
- 17241215
- 17241224
- Exp. Date 06/2026
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CARVEDILOL
- SevereCarvedilol Tablets 6.25 mg Recalled for N-Nitroso Impurity
FDA (Drugs) · 2025-06-04
- SevereCarvedilol Tablets Recalled Due to N-Nitroso Impurity
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- SevereCarvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit
FDA (Drugs) · 2025-06-04
- SevereCarvedilol Tablets 12.5 mg Recalled for Impurity Above Limit
FDA (Drugs) · 2025-06-04
- ModerateCarvedilol Tablets Recalled Due to CGMP Manufacturing Deviations
FDA (Drugs) · 2025-04-16
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