FDA drug recalls · openFDA
Is CARVEDILOL recalled?
The FDA has recorded 13 recalls of CARVEDILOL (2025) , recalled under brand like CARVEDILOL. 13 still ongoing.
0
Class I (most serious)
13
Class II
0
Class III
13
ongoing
A recall doesn't mean your pills are affected
Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of CARVEDILOL ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.
Why it was recalled
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit 4
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. 3
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended li 3
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. 2
CGMP Deviations 1
The recalls
Class I and ongoing recalls first. Tap a recall for its full record and lot detail.
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured f Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-02-28 lots: Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-02-28 lots: 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
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bard Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-08-07 lots: Lot#:19243202, Exp: 7/31/2026.
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactur Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-01-22 lots: 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.
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-01-22 lots: 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
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-02-28 lots: [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
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-08-06 lots: Lot #: 17241213, 17241215, 17241224, Exp. Date 06/2026
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-02-28 lots: [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
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-08-06 lots: Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-03-13 lots: Lot # 17240238, exp. date Jan-26 17240243, exp. date Jan-26 17240245, exp. date Jan-26 17240248, exp. date Jan-26
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162 Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-08-07 lots: Lot#: a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-08-07 lots: Lot#:19243104, Expires: 7/31/2026.
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceutica Class II ongoing
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-08-20 lots: Lot #: T05693, Exp. Date 03/2026
RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.