FDA Drug recall · Reported November 29, 2023
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,
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…
Glenmark Pharmaceuticals Inc., USA recalled Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottl… - a low-severity action.
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottl… was recalled by Glenmark Pharmaceuticals Inc., USA in November 29, 2023. Reason: Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic imp…. Check the official notice for the remedy. Verify recall #D-0112-2024 with the FDA Drug before acting.
The recall
Glenmark Pharmaceuticals Inc., USA issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic imp….
- Low
- severity level
- Class III
- classification
- November 29, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0112-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,472 drugs & medications recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0112-2024 |
| Date reported | November 29, 2023 |
| Date initiated | October 23, 2023 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Firm location | Mahwah, NJ |
| Affected scope | 8,448 30-count bottles, 168 1000-count bottles |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0112-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Drugs & Medications · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026