FDAHealthMay 15, 2025
Glenmark Pharmaceuticals Inc., USA — Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa
⚠️ OOS results reported for the Dissolution (by UV) test.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 15, 2025
Nationwide in the USA
What's affected?
- 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
- THEOPHYLLINE
- UPC
- 0368462380017
- Lot code
- 19234121
Additional details
Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 8,520 100-count bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.