Recall details are shown for all drugs with the same active ingredient as the chosen drug. Please read the Product Description carefully and consult the distribution map to determine if the recall effects you.
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.
Product Quantity: 18,696 bottles
Identifiers: Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
Recall Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Initiation Date: 02/28/2025 • Recall Number: D-0451-2025
Report Date: 06/04/2025 • Reporting Firm: Glenmark Pharmaceuticals Inc., USA
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
Product Quantity: 84,048 bottles
Identifiers: 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
Recall Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Initiation Date: 02/28/2025 • Recall Number: D-0450-2025
Report Date: 06/04/2025 • Reporting Firm: Glenmark Pharmaceuticals Inc., USA
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.
Product Quantity:
Identifiers: 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.
Recall Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Initiation Date: 01/22/2025 • Recall Number: D-0216-2025
Report Date: 02/12/2025 • Reporting Firm: Glenmark Pharmaceuticals Inc., USA
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.
Product Quantity:
Identifiers: 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
Recall Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Initiation Date: 01/22/2025 • Recall Number: D-0215-2025
Report Date: 02/12/2025 • Reporting Firm: Glenmark Pharmaceuticals Inc., USA
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.
Product Quantity: [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
Identifiers: [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
Recall Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Initiation Date: 02/28/2025 • Recall Number: D-0448-2025
Report Date: 06/04/2025 • Reporting Firm: Glenmark Pharmaceuticals Inc., USA
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.
Product Quantity: [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles
Identifiers: [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
Recall Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Initiation Date: 02/28/2025 • Recall Number: D-0449-2025
Report Date: 06/04/2025 • Reporting Firm: Glenmark Pharmaceuticals Inc., USA
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.
Product Quantity: N/A
Identifiers: Lot # 17240238, exp. date Jan-26 17240243, exp. date Jan-26 17240245, exp. date Jan-26 17240248, exp. date Jan-26
Recall Reason: CGMP Deviations
Initiation Date: 03/13/2025 • Recall Number: D-0336-2025
Report Date: 04/16/2025 • Reporting Firm: Glenmark Pharmaceuticals Inc., USA
Product Description: Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
Product Quantity: 7296 containers
Identifiers: Batch QG0619030-A, exp 11/2022
Recall Reason: Failed Impurities/Degradation Specifications
Initiation Date: 11/15/2021 • Recall Number: D-0263-2022
Report Date: 12/01/2021 • Reporting Firm: Aurobindo Pharma USA Inc.
Product Description: Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05
Product Quantity: 7668 bottles
Identifiers: Lot #: Z803518, Exp 08/2020
Recall Reason: Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Initiation Date: 04/22/2019 • Recall Number: D-1242-2019
Report Date: 05/01/2019 • Reporting Firm: Zydus Pharmaceuticals USA Inc
Product Description: Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Product Quantity: 2880 bottles
Identifiers: Z006279, exp 12/31/2022
Recall Reason: Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Initiation Date: 08/13/2021 • Recall Number: D-0753-2021
Report Date: 08/25/2021 • Reporting Firm: Zydus Pharmaceuticals (USA) Inc
Product Description: Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05
Product Quantity: 3900
Identifiers: Z804517, exp Nov 30, 2020
Recall Reason: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Initiation Date: 04/25/2019 • Recall Number: D-1273-2019
Report Date: 05/15/2019 • Reporting Firm: Zydus Pharmaceuticals USA Inc