Calcium Channel Blocker
Where is Diltiazem made?
34 companies sell it under their own name and 30 repackagers rebottle it. Their labels name 19 factories in India, Canada, the United States, China, Australia, Taiwan and 1 other.
India 9Canada 3United States 2China 2Australia 1Taiwan 1Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Bausch Health US, LLC Cardizem, Cardizem LA, Cardizem CD, Tiazacextended Release30 mg, 60 mg, 90 mg, 120 mg, 180 mg, 240 mg · NDC 0187-0792, 0187-2045, 0187-0795 +18 | Bausch Health Companies Inc.Makes it | Laval, Canada | No problems foundJan 2024 |
| Bausch Health Companies Inc.Makes it | Steinbach, Canada | No problems foundMay 2023 | |
| Cadila Healthcare Limited30 mg, 60 mg, 90 mg, 120 mg, 180 mg, 240 mg · NDC 70771-1030, 70771-1035, 70771-1932 +12 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| Caraco Pharmaceutical Laboratories, Ltd.120 mg, 180 mg, 240 mg, 300 mg, 360 mg · NDC 47335-675, 47335-669, 63304-718 +12 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Sun Pharmaceutical Industries LimitedMakes it | Mohali, India | Serious problems, FDA actionAug 2022 | |
| Oceanside Pharmaceuticals. Diltiazem HCl CD30 mg, 60 mg, 90 mg, 120 mg, 180 mg, 240 mg · NDC 68682-009, 68682-704, 68682-993 +18 | Bausch Health Companies Inc.Makes it, packages it and labels it | Laval, Canada | No problems foundJan 2024 |
| Bausch Health Companies Inc.Makes it and packages it | Steinbach, Canada | No problems foundMay 2023 | |
| Accord Healthcare Inc.120 mg, 180 mg, 240 mg · NDC 16729-303, 16729-304, 16729-305 | Intas Pharmaceuticals LimitedMakes it | Ahmedabad, India | No problems foundJul 2024 |
| Akorn5 mg per 1 mL · NDC 17478-937 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Alembic Pharmaceuticals Inc.30 mg, 60 mg, 90 mg, 120 mg, 180 mg, 240 mg · NDC 62332-725, 62332-784, 62332-815 +9 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited30 mg, 60 mg, 90 mg, 120 mg, 180 mg, 240 mg · NDC 46708-815, 46708-725, 46708-784 +9 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| AuroMedics Pharma LLC5 mg per 1 mL · NDC 55150-425, 55150-426, 55150-427 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Cipla USA., Inc.120 mg, 180 mg, 240 mg, 300 mg, 360 mg, 420 mg · NDC 69097-992, 69097-993, 69097-994 +3 | ScieGen Pharmaceuticals, INC.Makes it, tests it, packages it and labels it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Glenmark Pharmaceuticals Inc., USA60 mg, 90 mg, 120 mg · NDC 68462-562, 68462-850, 68462-851 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Hospira, Inc.5 mg per 1 mL, 100 mg · NDC 0409-4350, 0409-1171 | Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 |
| Ingenus Pharmaceuticals, LLC60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg · NDC 50742-248, 50742-566, 50742-249 +5 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Macleods Pharmaceuticals Limited120 mg, 180 mg, 240 mg, 300 mg, 360 mg · NDC 33342-521, 33342-522, 33342-523 +2 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Mayne Pharma Inc.60 mg, 90 mg, 120 mg · NDC 51862-330, 51862-328, 51862-329 | Mayne Pharma International Pty Ltd.Makes it, tests it, packages it and labels it | Salisbury South, Australia | Problems found, fixed voluntarilyMar 2025 |
| Northstar Rx LLC.120 mg, 180 mg, 240 mg · NDC 16714-523, 16714-524, 16714-525 | Apotex Inc.Makes it and tests it | Etobicoke, Canada | No problems foundSep 2024 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals120 mg, 180 mg, 240 mg, 300 mg, 360 mg, 420 mg · NDC 24658-170, 24658-171, 24658-172 +3 | Bausch Health Companies Inc.Makes it | Steinbach, Canada | No problems foundMay 2023 |
| ScieGen Pharmaceuticals, Inc.30 mg, 60 mg, 90 mg, 120 mg, 180 mg, 240 mg · NDC 50228-484, 50228-495, 50228-496 +7 | ScieGen Pharmaceuticals, INC.Makes it, tests it, packages it and labels it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Slate Run Pharmaceuticals, LLC.120 mg, 180 mg, 240 mg, 300 mg, 360 mg, 420 mg · NDC 70436-191, 70436-195, 70436-192 +6 | Yichang Humanwell Oral Solid Dosage PlantMakes it | Yichang, China | No problems foundJul 2023 |
| Upsher-Smith Laboratories, Inc.60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg · NDC 24979-026, 24979-183, 24979-027 +5 | Bora Pharmaceutical Laboratories Inc. Zhongli PlantMakes it, tests it and packages it | Taoyuan City, Taiwan | Problems found, fixed voluntarilyFeb 2020 |
| Viona Pharmaceuticals Inc.30 mg, 60 mg, 90 mg, 120 mg · NDC 72578-202, 72578-199, 72578-200 +1 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| WG Critical Care, LLC. DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE1 mg per 1 mL · NDC 44567-662, 44567-663 | InfoRLife SAMakes it, tests it, packages it and labels it | Campascio, Switzerland | Problems found, fixed voluntarilyMay 2024 |
| Zydus Pharmaceuticals (USA) Inc.120 mg, 180 mg, 240 mg, 300 mg, 360 mg, 420 mg · NDC 68382-595, 68382-745, 68382-596 +8 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Actavis Pharma, Inc.120 mg, 180 mg, 240 mg, 300 mg, 360 mg, 420 mg · NDC 62037-597, 52544-691, 62037-598 +7 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.120 mg, 180 mg, 240 mg · NDC 60505-0014, 60505-0015, 60505-0016 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cantrell Drug Company0.83 mg per 1 mL · NDC 52533-198 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.30 mg, 60 mg, 90 mg, 120 mg · NDC 62135-336, 62135-333, 62135-334 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cranbury Pharmaceuticals, LLC60 mg, 90 mg, 120 mg · NDC 27808-324, 27808-322, 27808-323 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.60 mg, 90 mg, 120 mg · NDC 75907-046, 75907-044, 75907-045 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.120 mg, 180 mg, 240 mg, 300 mg · NDC 10370-829, 10370-830, 10370-831 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.5 mg per 1 mL · NDC 0641-6013, 0641-6014, 0641-6015 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.60 mg, 90 mg, 120 mg · NDC 0378-6120, 0378-6060, 0378-6090 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals5 mg per 1 mL · NDC 25021-319 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.30 mg, 60 mg, 90 mg, 120 mg · NDC 0093-0321, 0093-0318, 0093-0319 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Diltiazem 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:
50090-1576,50090-2593,50090-3051,50090-6328+13 - Aidarex Pharmaceuticals LLC:
33261-951,53217-006,33261-847,33261-829+1 - American Health Packaging:
60687-195,60687-206,60687-217,60687-717+2 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-888,43353-889,43353-907,43353-906+1 - AvKARE, Inc.:
42291-030,73190-013,42291-028,73190-011+2 - Bryant Ranch Prepack:
71335-0745,63629-2154,71335-1223,71335-2129+29 - Cardinal Health 107, LLC:
55154-4317,55154-4321,55154-2627 - Carilion Materials Management:
68151-2111,68151-1480,68151-1457,68151-2112+3 - Coupler LLC:
67046-1417,67046-1481,67046-1560,67046-1492 - Direct Rx:
72189-248,72189-344,72189-409 - Dispensing Solutions Inc.:
68258-6024,68258-6046,66336-669 - Golden State Medical Supply, Inc.:
51407-473,84677-039,51407-474,84677-040+5 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1457,51662-1335,51662-1712 - Major Pharmaceuticals:
0904-7217,0904-7218,0904-7219,0904-7220 - McKesson Packaging Services Business Unit of McKesson Corporation:
63739-014,63739-015,63739-016 - Medical Purchasing Solutions, LLC.:
71872-7293,71872-7063,71872-7345 - Mylan Institutional Inc.:
51079-926,51079-924,51079-925 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8379,0615-8380,0615-8381,0615-8032+1 - Northwind Pharmaceuticals:
82868-036,82868-024,51655-020 - NuCare Pharmaceuticals.Inc.:
68071-4242,68071-4664,68071-4005 - Physicians Total Care, Inc.:
54868-4970,54868-3103,54868-2323,54868-5081+9 - Preferred Pharmaceuticals, Inc..:
68788-7870 - ProPharma Distribution:
84549-319 - Proficient Rx LP:
63187-769 - RPK Pharmaceuticals, Inc.:
53002-1521 - Rebel Distributors Corp..:
21695-403,21695-410,21695-404,21695-803+1 - Remedyrepack Inc.:
70518-3484,70518-2789 - Safecor Health, LLC:
48433-032,48433-030,48433-031 - State of Florida DOH Central Pharmacy:
53808-0830,53808-0612,53808-0695 - Unit Dose Services:
50436-6126
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations - Nov 1, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA · 3 recall notices
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. - Apr 17, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications - Mar 26, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study. - Jan 13, 2023 · Class II · Sun Pharmaceutical Industries Inc
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory. - Jul 21, 2022 · Class II · Teva Pharmaceuticals USA Inc
Failed Dissolution Specifications: below specification limits for dissolution. - Oct 27, 2021 · Class II · Teva Pharmaceuticals USA
Labelling: Incorrect Exp. Date - Sep 6, 2019 · Class III · Teva Pharmaceuticals USA
GMP Deviation: lot not intended for commercial distribution. - Jan 30, 2019 · Class III · Valeant Pharmaceuticals North America LLC · 5 recall notices
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. - Apr 23, 2018 · Class III · Mckesson Packaging Services · 2 recall notices
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.