Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMay 12, 2023 · 1 inspection |
Recalls
- Nov 11, 2025 · Class III · Dr. Reddy's Laboratories, Inc.
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Lots: Lot # F2400244, Exp Date: 10/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Varenicline: every company that makes it
- Form
- kit, oral
- Strength
- 1 mg / 0.5 mg
- Approval
- ANDA ANDA215931
- On the market since
- Dec 13, 2024
- Package NDCs
43598-023-53- Official label
- DailyMed (National Library of Medicine), updated Apr 25, 2025
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