Recall: D-0346-2025

Class II - Potentially Harmful

Class IIClassification

2025-03-13Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

Product

Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01

Reason

CGMP Deviations

Distribution

U.S. Nationwide

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