The detection of excess 'N-nitroso cinacalcet' impurity has led to the recall of the kidney drug cinacalcet hydrochloride.

The Ministry of Food and Drug Safety announced on the 17th that Huons’ Calcepara Tab 25 mg (cinacalcet hydrochloride) with 3 manufacturing numbers TTB201 (2025-08-16), TTB301 (2026-05-18), and TTB302 (2026-05-21) will be recalled by the manufacturer.

The cinacalcet hydrochloride-based formulations are used for the treatment of secondary hyperparathyroidism in patients with chronic kidney failure undergoing dialysis, and the original drug product, Regpara Tab (cinacalcet hydrochloride), was first recalled on November 20th.