Westminster Pharmaceuticals recalled 4,456 bottles of Metoprolol Tartrate Tablets on August 6, 2025. The recall follows the detection of a nitrosamine, N-nitroso-metoprolol, above acceptable daily intake levels. Consumers should immediately stop using this medication and consult healthcare providers.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Consumers and healthcare providers should stop using this product immediately. Contact Westminster Pharmaceuticals LLC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The recall involves Metoprolol Tartrate Tablets, USP, 100 mg, distributed by Westminster Pharmaceuticals. The affected batches include R56240011, R56240021, R56240031, R56240041, R56240051, R56240061, and R56240071, with expiration dates ranging from February 28, 2026, to July 31, 2026.
The recalled tablets contain N-nitroso-metoprolol, a nitrosamine that exceeds the established Acceptable Daily Intake level. Nitrosamines are known to pose potential cancer risks.
There are no reported incidents or injuries associated with this recall at this time. The recall is classified as Class II due to the potential health risk.
Consumers must stop using Metoprolol Tartrate Tablets immediately. Contact Westminster Pharmaceuticals or a healthcare provider for further guidance.
For more information, contact Westminster Pharmaceuticals at their customer service number or visit their website. Additional details can be found on the FDA recall page.
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