Approximately 9,330 cartons of Enalapril Maleate Tablets (2.5 mg and 5 mg), a medication used to treat high blood pressure and heart failure, have been recalled. The recall includes 3,397 cartons of the 2.5 mg strength and 5,933 cartons of the 5 mg strength. The manufacturer, Wockhardt, initiated this sub-recall after testing showed the product contained a degradation impurity (Enalapril DiKetopiperazine) that exceeded safe specifications. Consumers should identify if they have affected lots and contact their healthcare provider for guidance.
The product was found to have levels of a chemical impurity called Enalapril DiKetopiperazine that are higher than acceptable safety limits. This occurs when the active ingredient in the medication breaks down over time, which may potentially reduce the drug's effectiveness or introduce unwanted impurities into the patient's system.
Contact healthcare provider and return product for refund.
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Sources: FDA iRES · Raw API Response
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