FDA recall D-0582-2025

Product

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

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2025-08-06

Report date

2025-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nashville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0582-2025