Epoch HealthFDA Updates Recall on Blood Pressure Medication Due to Possible Carcinogen

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The FDA has updated its safety notice regarding a Class II recall of Nebivolol tablets manufactured by Aurobindo Pharma USA Inc. The recall stems from elevated levels of N-nitroso nebivolol, a nitrosamine impurity that exceeds acceptable intake limits. This marks the third blood pressure medication recall in recent weeks, following similar actions for Lisinopril and Ramipril, highlighting ongoing quality control challenges in antihypertensive medications.

Key Points:

• Aurobindo Pharma USA Inc. has initiated a recall of Nebivolol 2.5mg tablets in 30-count bottles due to nitrosamine impurity levels exceeding FDA acceptable limits. The affected lots are NB0224001A and NB0224001B, with an April 2027 expiration date and NDC 59651-137-30.
• The FDA classifies this as a Class II recall, indicating potential temporary health problems or a remote probability of serious health consequences. The presence of N-nitroso nebivolol, a mutagenic compound, prompted the action.
• Current FDA guidance states that daily exposure to nitrosamine levels at or below acceptable intake limits for 70 years is not expected to increase cancer risk. Patients should not discontinue their medications without consulting healthcare providers.
• Two other recent blood pressure medication recalls include Evaric Pharmaceuticals’ Lisinopril (10mg) due to metal fragment contamination, affecting 200,600 bottles, and Lupin Pharmaceuticals’ Ramipril for sourcing active ingredients from an unapproved vendor.
• A 2023 Journal of Pharmaceutical Analysis study emphasized that nitrosamine impurities, even in trace amounts, demonstrate significant genotoxic and mutagenic effects with potential DNA damage implications.

HCN Medical Memo
The clustering of three antihypertensive medication recalls within weeks necessitates increased vigilance in monitoring drug supply chains and patient medication management. Physicians should remain aware of alternative treatment options while maintaining clear communication with patients about continuing their current therapy until directed otherwise.

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