FDAHealthAugust 7, 2025
Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Gl
⚠️ CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 7, 2025
Nationwide in the USA
What's affected?
- Product
- Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05
- Brand
- CARVEDILOL
- UPC
- 0368462162019
- Lot code
- 19243202
Additional details
Lot#:19243202, Exp: 7/31/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6,432 bottles.
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