Class IIReported 2025-04-16

Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05.

Recalled by Glenmark Pharmaceuticals Inc., USA

Reason for Recall

CGMP Deviations

Recall Number

D-0336-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-03-13

Reported

2025-04-16

Distribution

U.S. Nationwide

Code Info

Lot # 17240238, exp. date Jan-26 17240243, exp. date Jan-26 17240245, exp. date Jan-26 17240248, exp. date Jan-26

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.