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Where is Carvedilol made?
19 companies sell it under their own name and 31 repackagers rebottle it. Their labels name 17 factories in India, the United States, Bangladesh, Canada and France.
India 12United States 2Bangladesh 1Canada 1France 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Advagen Pharma Ltd.3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 72888-501, 72888-036, 72888-502 +5 | Acme Generics Private LimitedMakes it, tests it, packages it and labels it | Solan, India | Problems found, fixed voluntarilyFeb 2026 |
| Axxelent Pharma Science Private LimitedMakes it, tests it and packages it | Tirupati, India | Not inspected on record | |
| Rubicon Research LimitedMakes it, tests it, packages it and labels it | Thane, India | No problems foundMar 2024 | |
| Cadila Healthcare Limited3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 65841-618, 65841-619, 65841-616 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| Zydus Pharmaceuticals LimitedMakes it and tests it | Matoda, India | Not inspected on record | |
| Zydus Pharmaceuticals (USA) Inc.3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 68382-094, 68382-095, 68382-092 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| Zydus Pharmaceuticals LimitedMakes it and tests it | Matoda, India | Not inspected on record | |
| Amneal Pharmaceuticals10 mg, 20 mg, 40 mg, 80 mg · NDC 69238-2577, 0115-1248, 69238-2578 +5 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 | |
| Aurobindo Pharma Limited3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 65862-144, 65862-145, 65862-142 +1 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 | |
| BluePoint Laboratories.3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 68001-151, 68001-152, 68001-153 +1 | Zydus Lifesciences LimitedMakes it | Solan, India | No problems foundMar 2020 |
| Zydus Pharmaceuticals LimitedMakes it | Matoda, India | Not inspected on record | |
| Glenmark Pharmaceuticals Inc., USA3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 68462-164, 68462-165, 68462-162 +1 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 | |
| Quallent Pharmaceuticals Health LLC3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 82009-127, 82009-128, 82009-125 +1 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Zydus Pharmaceuticals LimitedMakes it and tests it | Matoda, India | Not inspected on record | |
| Waylis Therapeutics LLC Coreg CR, Coreg3.125 mg, 6.25 mg, 10 mg, 12.5 mg, 20 mg, 25 mg · NDC 80725-383, 80725-141, 80725-385 +5 | Bora Pharmaceutical Services IncMakes it | Mississauga, Canada | Problems found, fixed voluntarilyJan 2025 |
| Meribel Pharma PessacMakes it | Pessac, France | Problems found, fixed voluntarilyJun 2024 | |
| Caraco Pharmaceutical Laboratories, Ltd.10 mg, 20 mg, 40 mg, 80 mg · NDC 57664-663, 57664-664, 57664-665 +1 | Frontida BioPharm, LLCMakes it | Philadelphia, PA, United States | No problems foundApr 2026 |
| Dr.Reddy's Laboratories Ltd.3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 55111-254, 55111-255, 55111-252 +1 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Northstar Rx LLC.10 mg, 20 mg, 40 mg, 80 mg · NDC 16714-227, 16714-228, 16714-229 +1 | Frontida BioPharm, LLCMakes it | Philadelphia, PA, United States | No problems foundApr 2026 |
| Unichem Pharmaceuticals (USA), Inc.3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 76385-112, 76385-113, 76385-110 +1 | Beximco Pharmaceuticals PLCMakes it | Tongi, Bangladesh | Problems found, fixed voluntarilyMar 2023 |
| Apotex Corp.10 mg, 20 mg, 40 mg, 80 mg · NDC 60505-3678, 60505-4713, 60505-3679 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Aurolife Pharma LLC3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 13107-144, 13107-145, 13107-142 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.10 mg, 20 mg, 40 mg, 80 mg · NDC 42291-479, 42291-480, 42291-481 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 10135-635, 10135-637, 10135-633 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Method Pharmaceuticals, LLC.3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 58657-752, 58657-753, 58657-750 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.3.125 mg, 6.25 mg, 12.5 mg, 25 mg · NDC 0093-7295, 0093-7296, 0093-0051 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Carvedilol in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-5115,50090-2079,50090-2555,50090-6878+17 - Aidarex Pharmaceuticals LLC:
33261-975,33261-537,33261-986,33261-848 - American Health Packaging:
68084-854 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-160,71610-066,43353-133,71610-067+6 - Blenheim Pharmacal, Inc.:
10544-190,10544-191,10544-184,10544-187 - Bryant Ranch Prepack:
71335-0308,63629-3669,71335-1813,71335-2026+19 - Cardinal Health 107, LLC:
55154-2648,55154-2640,55154-2641,55154-2649 - Carilion Materials Management:
68151-5048,68151-5049,68151-5050,68151-5051 - Coupler LLC:
67046-1551,67046-2005,67046-0879,67046-1006+4 - Direct Rx:
61919-728,72189-372,72189-690,61919-533+6 - Golden State Medical Supply, Inc.:
51407-050,51407-041,51407-051,51407-042+4 - H.J. Harkins Co., Inc.:
52959-204,52959-466 - Legacy Pharmaceutical Packaging:
68645-496 - Major Pharmaceuticals:
0904-6302,0904-7307,0904-6303,0904-7308+4 - MedVantx, Inc.:
66116-429,66116-361 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8389,0615-8390,0615-8387,0615-8388 - Northwind Pharmaceuticals:
51655-030,51655-397,51655-033,51655-034+3 - NuCare Pharmaceuticals.Inc.:
68071-2230,68071-4956,68071-2773,68071-2633+7 - PD-Rx Pharmaceuticals, Inc.:
43063-125,72789-537,43063-129,72789-440+4 - Physicians Total Care, Inc.:
54868-6019,54868-4396,54868-5773,54868-0106+8 - Preferred Pharmaceuticals, Inc..:
68788-0254,68788-7539,68788-9265,68788-8231+4 - Proficient Rx LP:
63187-447,82804-225,63187-131,63187-409+8 - QPharma, Inc.:
42708-072,42708-181 - RPK Pharmaceuticals, Inc.:
53002-1573,53002-1574,53002-1572,53002-1556 - Rebel Distributors Corp..:
42254-162 - RedPharm Drug Inc.:
67296-0681 - RedPharm Drug. Inc.:
67296-1900,67296-1497,67296-1899,67296-1901+1 - Remedyrepack Inc.:
70518-0356,70518-4389,70518-1826,70518-2389+3 - St. Mary's Medical Park Pharmacy:
60760-494,60760-582 - State of Florida DOH Central Pharmacy:
53808-0219,53808-0220,53808-0687,53808-1024+7 - Unit Dose Services:
70786-0144,70786-0145,70786-0142,50436-2607
Recalls
- Aug 20, 2025 · Class II · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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 7, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA · 3 recall notices
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. - Aug 6, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA · 2 recall notices
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations - Feb 28, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA · 4 recall notices
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit - Jan 22, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA · 2 recall notices
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. - Nov 15, 2021 · Class III · Aurobindo Pharma USA Inc.
Failed Impurities/Degradation Specifications - Aug 17, 2021 · Class II · RemedyRepack Inc.
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles. - Aug 13, 2021 · Class II · Zydus Pharmaceuticals (USA) Inc
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle - Apr 25, 2019 · Class II · Zydus Pharmaceuticals USA Inc
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg - Apr 22, 2019 · Class III · Zydus Pharmaceuticals USA Inc
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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.