CARVEDILOL
Recalling Firm / Manufacturer: Glenmark Pharmaceuticals Inc., USA
(Mahwah, NJ, United States)
FDA Recall Number: D-0448-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
CARVEDILOL
Generic Name
CARVEDILOL
Active Substance(s)
Carvedilol
Administration Route
Oral
National Drug Code (NDC)
68462-162
Total Quantity Recalled
[100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Full Product Description
Packaging specifications and labeling details
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
June 04, 2025
Firm Initiation Date
February 28, 2025
FDA Classification Date
May 28, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
[100-Count Bottles] Lot 19231450, Exp Mar-25, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lot 19240280, Exp DEC-25 [500-Count Bottles] Lot 19231450, 19231464, 19231471, 19231493, Exp Mar-25, 19232083, 19232103 Exp Apr-25, 19232658, Exp Jun-25; Lot 19233328, 19233343, 19233344, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lots 19234843, 19235039, Exp Nov-25; Lots 19240280, 19240296, Dec-25
Distribution Information
Geographic scope of affected shipments
U.S. Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0448-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508616UTCC