Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Havix Group Inc d/b/a Aavis Pharmaceuticals | Hoschton, GA, United States | Makes it | Problems found, fixed voluntarilyJul 25, 2025 · 2 inspections |
| Jubilant Generics Limited | Roorkee, India | Makes it | Problems found, fixed voluntarilyFeb 2, 2024 · 8 inspections, 3 with FDA action |
Recalls
- Jul 18, 2022 · Class II · Jubilant Cadista Pharmaceuticals, Inc.
Failed dissolution specifications.
Lots: Lot #: IB220023A, exp. date 08/2022 - Jul 18, 2022 · Class II · Jubilant Cadista Pharmaceuticals, Inc.
Failed Dissolution Specifications
Lots: Lot #: IB120012A, IB120013A, IB120014A Exp. date 08/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Irbesartan: every company that makes it
- Form
- tablet, oral
- Strength
- 75 mg
- Approval
- ANDA ANDA203534
- On the market since
- Feb 24, 2015
- Package NDCs
59746-447-0559746-447-3059746-447-90- Official label
- DailyMed (National Library of Medicine), updated Apr 21, 2026
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