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About the NATPARA
Recall

What You Need to Know

After discussions with the FDA, Takeda issued a US recall on September 5, 2019, for all doses of NATPARA® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg).

NATPARA is a parathyroid hormone currently approved in the US as the only adjunctive treatment for adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone (calcium and vitamin D).

With patient safety as the company’s main priority, Takeda is communicating directly with US healthcare professionals as well as with patients and specialty pharmacies. Discontinuing NATPARA abruptly can cause a sharp decrease in blood calcium levels (severe hypocalcemia) which can result in serious health consequences. It is critically important that patients contact their prescribing healthcare provider to discuss their individual treatment plan and ensure close supervision, including frequent monitoring of blood calcium levels and close titration of active vitamin D and calcium supplements upon stopping NATPARA to avoid low blood calcium (hypocalcemia).

All of us at Takeda understand the impact that this recall has on patients, and we are continuing to work closely with the FDA until we are able to resolve the issue. Takeda values the US FDA’s collaboration and feedback as we work together to resupply NATPARA to patients who need it.

If you have questions or concerns about this recall, browse the information on this page. For more details, read our PDF. Be sure to bookmark this page and check back often for the latest updates.

Latest Updates

Sorted by Most Recent

Letter to HCPs

January 21, 2020
Update on timeframe for NATPARA® (parathyroid hormone) availability
Download PDF version of Updated FDA Classification

Updated FDA Classification

October 9, 2019
FDA classifies NATPARA recall as a Class 1 recall requiring return of all unused product
Download PDF version of Updated FDA Classification

Special Use Letter for HCPs

September 24, 2019
Additional details about the NATPARA Special Use Program
Download PDF version of Letter to Patients

Special Use Program

September 24, 2019
Takeda announces NATPARA Special Use Program in the US
Download PDF version of Special Use Program

Recall Information

September 5, 2019
Takeda issues US recall of NATPARA due to the potential for rubber particulate
Download PDF version of Recall Information

NATPARA Special Use Program

Takeda has worked with the FDA to develop a Special Use Program for NATPARA. The program’s intent is to allow access to the drug by patients facing severe health consequences due to the inability to receive NATPARA. Physicians can submit a request to Takeda explaining the patient’s severe and/or life-threatening medical situation. An adjudication committee will review the requests on a case-by-case basis. Physicians who believe they have a patient meeting this criteria should email Takeda at NatparaSpecialUseProgram@Takeda.com. Download the PDF for full details.

Get Details

NATPARA® is a registered trademark of Shire-NPS Pharmaceuticals, Inc.

OnePath® is a registered trademark of Shire or its affiliates.

Q-Cliq is a trademark of Shire-NPS Pharmaceuticals, Inc.