Class IIReported 2025-06-04

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

Recalled by Glenmark Pharmaceuticals Inc., USA

Reason for Recall

OOS results reported for the Dissolution (by UV) test.

Recall Number

D-0452-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-05-15

Reported

2025-06-04

Distribution

Nationwide in the USA

Code Info

Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.