Recall of All Doses of Parathyroid Hormone Natpara Issued

The batch was distributed between August 14, 2018 and September 5, 2018.

Takeda announced a voluntary recall of all doses of Natpara (parathyroid hormone) injection (25mcg, 50mcg, 75mcg, 100mcg) due to the possible presence of small rubber particulates in the Natpara cartridge originating from the rubber septum.

Takeda is notifying healthcare professionals, patients, and specialty pharmacies regarding the recall. Natpara is supplied as a multiple-dose, dual-chamber glass cartridge containing a sterile powder and diluent; each Natpara cartridge delivers 14 doses. During this treatment period, the septum is punctured by a needle each day to obtain the daily dose, which may result in small rubber fragments detaching into the cartridge.

Natpara is a parathyroid hormone approved as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Healthcare professionals and patients are being advised not to abruptly discontinue Natpara therapy as stated in the product labeling due to the risk of severe hypocalcemia. In patients interrupting or discontinuing Natpara, resume treatment with, or increase the dose of, an active form of vitamin D and calcium supplements if indicated, and monitor for signs/symptoms of hypocalcemia and serum calcium levels.

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Healthcare providers with questions regarding the recall should contact (800) 828-2088 and select Option 2; patients with questions regarding the recall should contact (866) 888-0660.

As the recall involves all doses of Natpara, Takeda is working closely with the Food and Drug Administration to resolve the issue and resume supply of the product as quickly as possible.

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