Class II
Ongoing
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
This recall is currently active, issued August 20, 2025. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- August 8, 2025
- Posted
- August 20, 2025
- Recall Number
- D-0583-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 22,656 bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026
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