FDAFDA · Food and drugs·Recall number D-0583-2025
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
Published August 20, 2025 · Recall initiated: August 8, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- THEOPHYLLINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- USA nationwide.
- UPC
- 0368462380017
- Lot
- Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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