Recall: D-0452-2025

Class II - Potentially Harmful

Class IIClassification

2025-05-15Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

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

Reason

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.