Anthracycline Topoisomerase Inhibitor
Where is Doxorubicin made?
19 companies sell it under their own name. Their labels name 7 factories in India, the United States and China.
India 4United States 2China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| BluePoint Laboratories.2 mg per 1 mL · NDC 68001-629, 68001-704, 68001-703 +4 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Fordoz Pharma CorporationMakes it, tests it and packages it | East Windsor, NJ, United States | Serious problems, FDA actionNov 2025 | |
| Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 | |
| Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2025 | |
| Alembic Pharmaceuticals Inc.2 mg per 1 mL · NDC 62332-810, 62332-525 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Alembic Pharmaceuticals Limited2 mg per 1 mL · NDC 46708-810, 46708-525 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.2 mg per 1 mL · NDC 62756-826, 62756-827, 47335-049 +1 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Dr. Reddy's Laboratories Inc.2 mg per 1 mL · NDC 75907-363, 75907-364 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Fresenius Kabi, LLC2 mg per 1 mL · NDC 63323-883, 63323-101 | Fresenius Kabi USA, LLCMakes it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma Limited2 mg per 1 mL · NDC 68083-248, 68083-249, 68083-250 | Gland Pharma LimitedMakes it, tests it and packages it | Visakhapatnam, India | No problems foundJul 2023 |
| Northstar Rx LLC.2 mg per 1 mL · NDC 72603-103, 72603-200 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Qilu Pharmaceutical Co., Ltd.2 mg per 1 mL · NDC 67184-0623, 67184-0624 | Qilu Pharmaceutical (Hainan) Co., Ltd.Makes it, tests it and packages it | Haikou, China | Problems found, fixed voluntarilyMay 2023 |
| Zydus Lifesciences Limited2 mg per 1 mL · NDC 49315-008, 49315-009 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2025 |
| Zydus Pharmaceuticals (USA) Inc.2 mg per 1 mL · NDC 70710-1530, 70710-1531 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2025 |
| Actavis Pharma, Inc.2 mg per 1 mL · NDC 45963-733 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals LLC2 mg per 1 mL · NDC 70121-1218, 70121-1219 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Baxter Healthcare Corporation Doxil2 mg per 1 mL · NDC 0338-0080, 0338-0086, 0338-9581 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.2 mg per 1 mL · NDC 0143-9088, 0143-9089, 0143-9090 +17 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lupin Pharmaceuticals, Inc.2 mg per 1 mL · NDC 70748-339, 70748-340 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC2 mg per 1 mL · NDC 67457-478, 67457-436 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pfizer Laboratories Div Pfizer Inc Doxorubicin Hydrochloride2 mg per 1 mL · NDC 0069-4004, 0069-4015, 0069-4026 +16 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals2 mg per 1 mL · NDC 25021-207, 25021-263 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- May 12, 2026 · Class I · Sun Pharmaceutical Industries Inc
Presence of Particulate matter: Particulate matter identified as glass. - Aug 24, 2023 · Class II · Baxter Healthcare Corporation
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake. - Nov 17, 2020 · Class III · Fresenius Kabi USA, LLC
Cross Contamination with Other Products: trace amounts of octreotide found during testing - Jan 16, 2018 · Class II · Sun Pharmaceutical Industries, Inc.
Lack Of Assurance Of Sterility
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.