US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Mar 13, 2025 (1 years ago)

Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations

What was recalled

Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-424-30

Recalling firm
Glenmark Pharmaceuticals Inc., USA
NDC code
68462-424-30
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0334-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.