WhichRecall
Class IIReported 2025-08-20

Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10

Recalled by Westminster Pharmaceuticals LLC

Reason for Recall

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Advertisement
Recall Number
D-0582-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-08-06
Reported
2025-08-20
Distribution
Nationwide in the USA.
Code Info
Batch # R56240011, Exp Date: 2/28/26; Batch # R56240021, R56240031, Exp Date: 3/31/26; Batch # R56240041, R56240051, R56240061, Exp Date: 4/30/26; Batch # R56240071, Exp Date: 7/31/26
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
Advertisement