Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
Recalls
- Jan 29, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots: Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Atomoxetine: every company that makes it
- Form
- capsule, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA079019
- On the market since
- May 30, 2017
- Package NDCs
68462-265-2368462-265-30- Official label
- DailyMed (National Library of Medicine), updated Sep 29, 2026
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