Recall
FDAHealthMarch 13, 2025

Glenmark Pharmaceuticals Inc., USA — Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, P

⚠️ 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
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
Lot code
17232460

Additional details

Lot # 17232460, exp. date Nov-25 17232460, exp. date Nov-25 17241194, exp. date Jun-26 17241194, exp. date Jun-26

What should I do?

Recommended action

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

View original FDA notice →

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