Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyMar 24, 2023 · 5 inspections |
Recalls
- Sep 24, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lots: Lot#: E409308, Exp 12/31/2026 - Sep 24, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lots: Lot#: E409309, Exp 12/31/2026 - Sep 4, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Impurity/Degradation Specifications
Lots: Lot E309376; Exp 11/30/2025 - Sep 4, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Impurity/Degradation Specifications
Lots: Lot E309377, Exp 11/30/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Entecavir: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 0.5 mg
- Approval
- ANDA ANDA206745
- On the market since
- Aug 10, 2017
- Package NDCs
68382-920-0168382-920-0668382-920-1668382-920-3068382-920-77- Official label
- DailyMed (National Library of Medicine), updated Oct 5, 2023
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?