Westminster Pharmaceuticals recalled 16,672 bottles of Metoprolol Tartrate Tablets on August 6, 2025. The recall stems from high levels of a harmful nitrosamine, N-nitroso-metoprolol, exceeding the Acceptable Daily Intake. Consumers must stop using the tablets immediately and consult healthcare providers for guidance.
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, 50 mg, with NDC 69367-354-10. Distributed by Westminster Pharmaceuticals, the affected batches include R55230021, R55230031, R55230041, and others, with expiration dates ranging up to December 31, 2025.
The recalled Metoprolol Tartrate Tablets contain N-nitroso-metoprolol, a nitrosamine that poses a high risk due to potential carcinogenic effects. This contamination exceeds the established Acceptable Daily Intake, leading to serious health concerns.
No specific incidents of injury or death have been reported related to this recall. However, the presence of the nitrosamine raises significant health risks.
Consumers should stop using the recalled tablets immediately. Contact Westminster Pharmaceuticals LLC or consult your healthcare provider for advice on alternative treatments.
For further assistance, consumers can reach Westminster Pharmaceuticals at their customer service number or visit their website. Additional information is available at the FDA recall page.
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