# FDA recall D-0583-2025

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2025-08-08.

## Product

Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01

## Reason for recall

Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0583-2025
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-08
- **Report date:** 2025-08-20

- **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-0583-2025

## Citation

> AI Analytics. FDA recall D-0583-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0583-2025. Source: US FDA. Licensed CC0.

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