Class II

Drug Recall: 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: Gl

Glenmark Pharmaceuticals Inc., USA · May 15, 2025

Reason for Recall

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

Product Description

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

8,520 100-count bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0452-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.