Carvedilol recalls: 17 FDA reports
Recalls involving Carvedilol. What was wrong with each batch, and how the FDA graded the risk.
17Reports
0Class I
13Ongoing
2025-08-27Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pha
D-0594-2025 · Class II · reported 2025-08-27 · Ongoing
- Why it was recalled
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Product
- Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
- Where it went
- Product was distributed nationwide within the United States.
- How much
- 26,628 cartons
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Co
D-0578-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- 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
- Where it went
- Nationwide in the USA
- How much
- 6,432 bottles
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd
D-0588-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Product
- 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
- Where it went
- Nationwide within the USA
- How much
- 14,976 bottles
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals L
D-0587-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Product
- 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
- Where it went
- Nationwide within the USA
- How much
- 17, 496 bottles
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC
D-0577-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Product
- 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.
- Where it went
- Nationwide in the USA
- How much
- 44,328 bottles
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colv
D-0579-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Product
- 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
- Where it went
- Nationwide in the USA
- How much
- 4,800 bottles
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manu
D-0451-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Product
- 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.
- Where it went
- U.S. Nationwide
- How much
- 18,696 bottles
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Man
D-0450-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Product
- 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
- Where it went
- U.S. Nationwide
- How much
- 84,048 bottles
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 6846
D-0448-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Product
- 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.
- Where it went
- U.S. Nationwide
- How much
- [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05
D-0449-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Product
- 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.
- Where it went
- U.S. Nationwide
- How much
- [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,
D-0336-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- 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.
- Where it went
- U.S. Nationwide
- How much
- N/A
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01,
D-0216-2025 · Class II · reported 2025-02-12 · Ongoing
- Why it was recalled
- CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
- Product
- 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.
- Where it went
- Nationwide in the U.S
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Ma
D-0215-2025 · Class II · reported 2025-02-12 · Ongoing
- Why it was recalled
- CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
- Product
- 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.
- Where it went
- Nationwide in the U.S
Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279
D-0263-2022 · Class III · reported 2021-12-01 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- 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
- Where it went
- Nationwide in the US
- How much
- 7296 containers
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, D
D-0753-2021 · Class II · reported 2021-08-25 · Terminated
- Why it was recalled
- Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
- Product
- 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
- Where it went
- Nationwide in the US
- How much
- 2880 bottles
Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Di
D-1273-2019 · Class II · reported 2019-05-15 · Terminated
- Why it was recalled
- Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
- Product
- 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
- Where it went
- Nationwide
- How much
- 3900
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India;
D-1242-2019 · Class III · reported 2019-05-01 · Terminated
- Why it was recalled
- 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.
- Product
- 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
- Where it went
- Nationwide in the USA
- How much
- 7668 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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