Esomeprazole Magnesium Delayed-Release Capsules — Class III drug recall D-0112-2024
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2023-11-29, distributed nationwide. Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impu
| Recall number | D-0112-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2023-10-23 |
| Classified | 2023-11-20 |
| Reported by FDA | 2023-11-29 |
| Terminated | 2024-07-05 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68462-0390, 68462-0390-10, 68462-0390-30, 68462-0390-90, 68462-0391, 68462-0391-10, 68462-0391-30, 68462-0391-90 |
| Lot numbers | 17220002 |
| Expiration dates | 2023-11-30 |
Product
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
Reason for recall
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0112-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.