NDC 82009-022
Omeprazole 20 mg capsule, delayed release
On the label: Quallent Pharmaceuticals Health LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Recalls
- Jun 30, 2025 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Lots: Lot: C2403017, Exp 12/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Omeprazole: every company that makes it
- Form
- capsule, delayed release, oral
- Strength
- 20 mg
- Approval
- ANDA ANDA075576
- On the market since
- Nov 15, 2022
- Package NDCs
82009-022-10- Official label
- DailyMed (National Library of Medicine), updated Nov 28, 2025
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