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FDAFDA · Food and drugs·Recall number D-0339-2025

Rosuvastatin Tablets 40mg, 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# 68462-264-30

Published April 16, 2025 · Recall initiated: March 13, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
ROSUVASTATIN CALCIUM
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Distributor
U.S. Nationwide
UPC
0368462263907
Lot
Lot # 17240389, exp. date Feb-26 17240390, exp. date Feb-26 17240426, exp. date Feb-26 17240427, exp. date Feb-26 17240428, exp. date Feb-26 17240778, exp. date Apr-26 17241055, exp. date May-26 17241074, exp. date Jun-26 17241075, exp. date Jun-26 17241091, exp. date Jun-26 17241100, exp. date Jun-26
Risk classification
Class II
Area (FDA)
drug
Country
United States

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