CARVEDILOL (CARVEDILOL)
Pending LLM rewrite. Source: FDA_DRUG D-0587-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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 #: 17241257
- 17241258
- 17241279
- Exp. Date 06/2026
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CARVEDILOL
- SevereCarvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit
FDA (Drugs) · 2025-06-04
- SevereCarvedilol Tablets Recalled Due to N-Nitroso Impurity
FDA (Drugs) · 2025-06-04
- SevereCarvedilol Tablets 6.25 mg Recalled for N-Nitroso Impurity
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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