Recalls / Class II
Class IID-0583-2025
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
- Brand name
- Theophylline
- Generic name
- Theophylline
- Active ingredient
- Theophylline Anhydrous
- Route
- Oral
- NDCs
- 68462-356, 68462-380
- FDA application
- ANDA090355
- Affected lot / code info
- Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026
Why it was recalled
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.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 22,656 bottles
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2025-08-08
- FDA classified
- 2025-08-12
- Posted by FDA
- 2025-08-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0583-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.