Class IIOngoing

Theophylline (Anhydrous) Extended-Release Tablets recall

FDA recall D-0452-2025 · initiated May 15, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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
Recalling company: Glenmark Pharms
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: May 15, 2025
FDA report date: Jun 4, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0452-2025 ↗

← All drug recalls