Recall
FDAHealthMarch 13, 2025

Glenmark Pharmaceuticals Inc., USA — Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufa

⚠️ CGMP Deviations

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 13, 2025

U.S. Nationwide

What's affected?

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
UPC
0368462189016
Lot code
17231956

Additional details

Lot # 17231956, exp. date Aug-25

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: N/A.

View original FDA notice →

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