NDC 68382-848
Esomeprazole Magnesium 20 mg granule, delayed release
On the label: Zydus Pharmaceuticals (USA) Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Recalls
- May 13, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Lots: Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026. - May 13, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Lots: Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026. - Nov 14, 2024 · Class III · Zydus Pharmaceuticals (USA) Inc
Labeling: Not Elsewhere Classified - Wrong NDC number
Lots: Lot#: M408002, Exp 05/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Esomeprazole: every company that makes it
- Form
- granule, delayed release, oral
- Strength
- 20 mg
- Approval
- ANDA ANDA206055
- On the market since
- Jun 30, 2023
- Package NDCs
68382-848-94- Official label
- DailyMed (National Library of Medicine), updated Aug 17, 2023
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