# FDA recall D-0112-2024

> **Glenmark Pharmaceuticals Inc., USA** · Class III · drug recall initiated 2023-10-23.

## 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).

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0112-2024
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-10-23
- **Report date:** 2023-11-29
- **Termination date:** 2024-07-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0112-2024

## Citation

> AI Analytics. FDA recall D-0112-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0112-2024. Source: US FDA. Licensed CC0.

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