Sun Pharmaceutical Industries Inc’s US subsidiary has voluntarily recalled 11,328 bottles of Spironolactone tablets after traces of aluminium contamination were discovered.

The medication, manufactured by Frontida BioPharm in Philadelphia, was pulled back under a Class II recall classification by the US Food and Drug Administration, indicating potential temporary or medically reversible health effects, with a low risk of serious consequences.

The recall, which began on 5 August 2025, followed a consumer complaint about a “dark fragment” found in a tablet. Spironolactone is widely prescribed to treat high blood pressure, oedema, and heart failure by blocking aldosterone receptors in the kidneys.