Class II Recall for Metoprolol Tartrate Tablets Due to Nitrosamine Contamination

The US Food and Drug Administration (FDA) has issued a Class II recall for Metoprolol Tartrate Tablets, USP in both 50 mg and 100 mg strengths, packaged in 1000-count bottles, due to the presence of N-nitroso-metoprolol, a nitrosamine impurity found at levels exceeding the established Acceptable Daily Intake (ADI). The recall includes more than 21 000 bottles across multiple batches, with expiration dates ranging from September 2025 through July 2026. The products were manufactured by Renata PLC in Bangladesh and distributed in the U.S. by Westminster Pharmaceuticals, LLC, based in Nashville, Tennessee. The voluntary recall began on August 6, 2025, and is currently ongoing with nationwide distribution.

The recall was officially classified as Class II by the FDA on August 12, 2025, indicating that use of the product may cause temporary or medically reversible adverse health effects, though the risk of serious harm is considered low. Nitrosamines such as N-nitroso-metoprolol are classified as probable human carcinogens, and long-term exposure above acceptable limits may increase cancer risk. The recalling firm has contacted consignees through multiple channels, including email, fax, letter, and direct outreach. No public press release has been issued to date.

Metoprolol tartrate is a beta-blocker prescribed for the treatment of hypertension, angina pectoris, and to improve survival after myocardial infarction. Pharmacists should review their inventory for impacted batch numbers, including R55230021 through R56240071, and remove affected stock to prevent inadvertent dispensing.