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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, who have already received this information, 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, and talk with your doctor. 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 Patients

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

Letter to Patients

September 25th, 2019
Additional details about the NATPARA Special Use Program
Download PDF version of Letter to Patients

Special Use Program

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

Recall Press Release

September 13th, 2019
Message about the US NATPARA Recall
Download PDF version of Recall Press Release

Recall Information

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

A Message to Our Patients

All of us at Takeda understand the NATPARA recall in the US has been extremely difficult for patients, their families, and caregivers.

Discussions with the FDA are focused on both short- and long-term solutions to bring this critical medicine back to patients. As we continue to work with the FDA on this issue, we will keep patients and healthcare providers informed as more information becomes available.

We encourage you to talk with your healthcare provider to see if you qualify for the Special Use Program. Through this program, healthcare providers can request NATPARA for patients facing life-threatening complications as a result of discontinuing NATPARA.

We are dedicated to the hypoparathyroidism community and the resupply of NATPARA for all patients.

— Dan McNamara, Takeda’s Vice President of US Patient Services

Read Dan’s Full Letter

NATPARA Special Use Program

If you are a patient previously prescribed NATPARA who is facing life-threatening complications as a result of discontinuation of NATPARA, despite efforts to actively manage your condition, your healthcare provider will be able to request NATPARA for you. The Medical Review committee will then evaluate eligibility on a case-by-case basis.

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OnePath® is Here to Help

Our experienced Patient Support Managers can work with you one-on-one to answer your questions at 1-866-888-0660, Monday through Friday 8:30 a.m. to 8:00 p.m. ET.

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