Glenmark Recalls Theophylline Extended-Release Tablets Over Failed Dissolution Testing

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall of theophylline (anhydrous) extended-release tablets, 600 mg, following out-of-specification (OOS) results during dissolution testing by ultraviolet (UV) analysis. The affected product, packaged in 100-count bottles (NDC: 68462-356-01), includes 4 impacted lots (19234121, 19234148, 19242881, 19242899) with expiration dates ranging from September 30, 2025 to June 30, 2026. A total of 8520 bottles were distributed nationwide in the US.

The recall, classified under number D-0452-2025 and event ID 96867, was voluntarily initiated by the firm on May 15, 2025, and remains ongoing. Notification to consignees was issued via letter. While no public press release has been issued, the FDA’s classification as Class II reflects the possibility of temporary or medically reversible adverse health effects due to product performance concerns—specifically, inconsistent release of active ingredient over time.

Theophylline is a methylxanthine bronchodilator indicated for the treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, such as chronic bronchitis and emphysema. Pharmacists should promptly review inventory for affected lots and coordinate returns in accordance with recall procedures to mitigate potential patient risk.