Carvedilol Tablet, Film Coated
FDA Recall NDC 68462-162
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 12 recorded enforcement report(s) associated with Carvedilol (NDC 68462-162). A significant event, classified as Class II, was initiated on Aug 07, 2025 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
D-0587-2025D-0588-2025D-0578-2025D-0579-2025D-0577-2025D-0449-2025D-0451-2025D-0448-2025D-0450-2025D-0336-2025D-0216-2025D-0215-2025
Class II Ongoing
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Aug 06, 2025
Aug 20, 2025
17, 496 bottles
Recall Profile & Regulatory Data
Event ID
97372
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA
Product Description
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
Batch or Lot Expiration Information
Lot# : 17241257, 17241258, 17241279, Exp. Date 06/2026
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
Class II Ongoing
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Aug 06, 2025
Aug 20, 2025
14,976 bottles
Recall Profile & Regulatory Data
Event ID
97372
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA
Product Description
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
Batch or Lot Expiration Information
Lot# : 17241213, 17241215, 17241224, Exp. Date 06/2026
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
Class II Ongoing
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Aug 07, 2025
Aug 20, 2025
6,432 bottles
Recall Profile & Regulatory Data
Event ID
97370
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Batch or Lot Expiration Information
Lot# :19243202, Exp: 7/31/2026.
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
Class II Ongoing
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Aug 07, 2025
Aug 20, 2025
4,800 bottles
Recall Profile & Regulatory Data
Event ID
97370
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Carvedilol Tablets, USP, 25 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 68462-165-05
Batch or Lot Expiration Information
Lot# :19243104, Expires: 7/31/2026.
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
Class II Ongoing
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Aug 07, 2025
Aug 20, 2025
44,328 bottles
Recall Profile & Regulatory Data
Event ID
97370
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
Batch or Lot Expiration Information
Lot# : a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
February 2025 Class II Recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Recall Number
Class II Ongoing
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Feb 28, 2025
Jun 04, 2025
[100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles
Recall Profile & Regulatory Data
Event ID
96861
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Batch or Lot Expiration Information
Lot# [100-Count Bottles] Lot 19231618, exp Mar-25; 19232064, exp Apr-25; 19232324, May-25; 19233369, Exp Jul-25; Lot 19234162, Exp Sep-25; Lot 19240543, Exp Jan-26 [500-Count Bottles] Lots 19231174, 19231199, 19231164, Exp Feb-25, 19231517,19231527, 19231566,19231568,19231595, 19231618,19231634,19231638, 19231448, Exp Mar-25, 19232043,19232051,19232064, Apr-25, 19232322, 19232324, 19232365, 19232380, 19232389, Exp May-25; Lots 19232736, 19232743, 19232746, 19232756, 19232757, Exp Jun-25; Lots 19233369, 19233371, 19233405, 19233416, Exp Jul-25; Lots 19234162, 19234183, 19234192, 19234204, 19234223, 19234243, 19234263, 19234165, 19234242, Exp Sep-25; Lots 19234743, 19234774, 19234993, Exp Nov-25; Lots 19240223, 19240203, 19240211, 19240214, 19240247, 19240249, 19240272, 19240319, Exp Dec-25; Lot 19240543, Exp Jan-26
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
February 2025 Class II Recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Recall Number
Class II Ongoing
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Feb 28, 2025
Jun 04, 2025
18,696 bottles
Recall Profile & Regulatory Data
Event ID
96861
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.
Batch or Lot Expiration Information
Lot# Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
February 2025 Class II Recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Recall Number
Class II Ongoing
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Feb 28, 2025
Jun 04, 2025
[100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
Recall Profile & Regulatory Data
Event ID
96861
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# [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
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
February 2025 Class II Recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Recall Number
Class II Ongoing
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Feb 28, 2025
Jun 04, 2025
84,048 bottles
Recall Profile & Regulatory Data
Event ID
96861
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05
Batch or Lot Expiration Information
Lot# Lot, Exp: Lots 19231899, 19231922, 19231927, 19231967, 19231979, Exp Apr-25; Lots 19232226, 19232234, 19232265, 1923227,1 Exp May-25; Lots 19232758, 19232759, 19232762, 19232788, Exp Jun-25
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
Class II Ongoing
CGMP Deviations
Mar 13, 2025
Apr 16, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96474
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05.
Batch or Lot Expiration Information
Lot# 17240238, exp. date Jan-26 17240243, exp. date Jan-26 17240245, exp. date Jan-26 17240248, exp. date Jan-26
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
Class II Ongoing
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Jan 22, 2025
Feb 12, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96162
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S
Product Description
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Batch or Lot Expiration Information
Lot# Lot numbers: a) 17230658, Exp.: 02/2025; 17230814,17230822, Exp.: 03/2025; 17231004,17231009,17231022, Exp.: 04/2025; 17231393,17231392, Exp.: 05/2025; 17231538, 17231541,17231542, Exp.: 06/2025; 17231710,17231718,17231721,17231722,17231730, Exp': 07/2025; 17232169, Exp.: 09/2025; 17232253, Exp.: 10/2025; 17240220,17240240, Exp.: 01/2026; 17240459, Exp.: 02/2026 b) 17230814, Exp.: 03/2025; 17231392, Exp.:05/2025; 17232260, Exp.: 10/2025.
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
Class II Ongoing
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Jan 22, 2025
Feb 12, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96162
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S
Product Description
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Batch or Lot Expiration Information
Lot# Lot numbers: a) 17230500, 17230509,17230526,17230546,17230551,17230603,17230628, 17230642,17230645,17230681, Exp.:02/2025; 17230829,17230832,17230854, 17230864,17230874,17230876,17230889,17230894, Exp.: 03/2025; 17230960, 17230964,17230976,17230981,17230985,17231161,17231171, Exp.: 04/2025 17231315,17231318,17231332,17231333,17231365, Exp.: 05/2025; 17231539, 17231563, Exp.: 06/2025; 17231653,17231662,17231663,17231680,17231691, 17231781,17231782,17231789, Exp.: 07/2025;17231838,17231880, Exp.: 08/2025; 17232144,17232147,17232151, Exp.: 09/2025; 17232369,17232370,17232408,17232409, 17232416,17232504,17232522,17232531,17232538,17232543, Exp.: 11/2025; 17240377,17240385,17240415,17240422,17240430,17240510, Exp.: 02/2026. b) 17230551, 17240377, Exp.:02/2025
Affected Packages Involved in this Recall
68462-162-60Product
68462-162-01Product
68462-162-18Product
68462-162-05Product
68462-162-10Product
68462-163-60Product
68462-163-01Product
68462-163-18Product
68462-163-05Product
68462-163-10Product
68462-164-60Product
68462-164-01Product
68462-164-18Product
68462-164-05Product
68462-164-10Product
68462-165-60Product
68462-165-01Product
68462-165-18Product
68462-165-05Product
68462-165-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
