Glenmark Pharmaceuticals Inc., USA recalls Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Ph
Recalled June 4, 2025 · FDA recall D-0452-2025 · Glenmark Pharmaceuticals Inc., USA
Hazard
OOS results reported for the Dissolution (by UV) test. · FDA Class II
Units
8,520 100-count bottles
Sold at
Nationwide in the USA
Description
OOS results reported for the Dissolution (by UV) test.
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
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →