[pending] CARVEDILOL (CARVEDILOL)
Pending LLM rewrite. Source: FDA_DRUG D-0579-2025.
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 of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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 (2)
- Lot#:19243104
- Expires: 7/31/2026.
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CARVEDILOL
- HighCarvedilol Tablets Recalled for Carcinogenic N-Nitroso Impurity Manufacturing Defect
FDA (Drugs) · 2025-02-12
- HighPrescription Carvedilol recalled for manufacturing impurity exceeding FDA specifications
FDA (Drugs) · 2025-02-12
- 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
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27