FDA Drug recall D-0112-2024
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30
- FDA Drug
- Class III
- terminated
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class III recall of Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30 by Glenmark Pharmaceuticals Usa, citing 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 s….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0112-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-10-23 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
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).
Identifiers
| ndc | 68462-390-30 |
|---|---|
| ndc | 68462-390-90 |
| ndc | 68462-390-10 |
| ndc | 68462-391-30 |
| ndc | 68462-391-90 |
| ndc | 68462-391-10 |
| code_info | Lot # 17220002, Exp Date 11/30/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class III · 2025-12-17 · Glenmark Pharmaceuticals Usa - Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30
FDA Drug · Class III · 2025-12-10 · Glenmark Pharmaceuticals Usa
All Glenmark Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0112-2024%22
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