Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Where is Entecavir made?
15 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 12 factories in India, China, the United States and Taiwan.
India 5China 5United States 1Taiwan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.0.5 mg, 1 mg · NDC 69097-426, 69097-425 | Cipla LimitedMakes it, tests it, packages it and labels it | Indore, India | Serious problems, FDA actionFeb 2023 |
| Cipla LimitedMakes the active ingredient | Pune, India | Problems found, fixed voluntarilyMay 2024 | |
| Northstar Rx LLC.0.5 mg, 1 mg · NDC 16714-717, 16714-718 | Cipla LimitedMakes it, tests it, packages it and labels it | Indore, India | Serious problems, FDA actionFeb 2023 |
| Cipla LimitedMakes the active ingredient | Pune, India | Problems found, fixed voluntarilyMay 2024 | |
| Yaopharma Co., Ltd.0.5 mg, 1 mg · NDC 50771-013, 50771-014 | Chongqing Carelife Pharmaceutical Co., LtdMakes the active ingredient | Chongqing, China | No problems foundMar 2024 |
| Yaopharma Co., Ltd.Makes it | Chongqing, China | Problems found, fixed voluntarilyMar 2019 | |
| Amneal Pharmaceuticals0.5 mg, 1 mg · NDC 65162-446, 65162-449 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Aurobindo Pharma Limited0.5 mg, 1 mg · NDC 65862-841, 65862-842 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cadila Healthcare Limited0.5 mg, 1 mg · NDC 70771-1019, 70771-1020 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Camber Pharmaceuticals Inc.0.5 mg, 1 mg · NDC 31722-833, 31722-834 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Cameron Pharmaceuticals0.5 mg, 1 mg · NDC 42494-457, 42494-458 | Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.Makes it | Jinhua, China | Problems found, fixed voluntarilyApr 2025 |
| Carlsbad Technology, Inc.0.5 mg · NDC 61442-311 | Yung Shin Pharm. Ind. Co., Ltd. (taichung Youth Factory)Makes it | Taichung City, Taiwan | Problems found, fixed voluntarilyOct 2019 |
| Epic Pharma, LLC0.5 mg, 1 mg, 1.0 mg · NDC 42806-658, 42806-667, 42806-659 +1 | Visum Pharmaceutical Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilySep 2026 |
| Solco Healthcare U.S., LLC0.5 mg, 1 mg · NDC 43547-436, 43547-437 | Zhejiang Huahai Pharmaceutical Co., Ltd.Makes it | Linhai, China | Serious problems, FDA actionApr 2026 |
| Zydus Pharmaceuticals (USA) Inc.0.5 mg, 1 mg · NDC 68382-920, 68382-921 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| AvKARE, Inc.0.5 mg, 1 mg · NDC 42291-261, 42291-262 | The label doesn't name the factory. Plants this company names for other drugs | ||
| E.R. Squibb & Sons, L.L.C. Baraclude0.05 mg per 1 mL, 0.5 mg, 1.0 mg · NDC 0003-1614, 0003-1611, 0003-1612 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.0.5 mg, 1 mg · NDC 10135-615, 10135-616 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Entecavir 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.
Recalls
- Sep 24, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc · 2 recall notices
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity - Sep 4, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc · 2 recall notices
Failed Impurity/Degradation Specifications - Jul 20, 2017 · Class II · Hetero USA Inc
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.