Recalls / Class II
Class IID-0452-2025
Product
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01
- Brand name
- Theophylline
- Generic name
- Theophylline
- Active ingredient
- Theophylline Anhydrous
- Route
- Oral
- NDCs
- 68462-356, 68462-380
- FDA application
- ANDA090355
- Affected lot / code info
- Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
Why it was recalled
OOS results reported for the Dissolution (by UV) test.
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
- 8,520 100-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-05-15
- FDA classified
- 2025-05-28
- Posted by FDA
- 2025-06-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0452-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.