CLASS I Drug recall · Reported 2 Oct 2019 · FDA Enforcement Report
Natpara (parathyroid hormone) for Injection, 25 mcg/dose cartridges recalled
Shire Human Genetic Therapies is recalling Natpara (parathyroid hormone) for Injection, 25 mcg/dose cartridges, distributed nationwide in the US. The recall was initiated on 12 Sep 2019 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0035-2020
- FDA event ID
- 83792
- Recalling firm
- Shire Human Genetic Therapies, Lexington, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 12 Sep 2019
- FDA classified
- 1 Oct 2019
- Reported
- 2 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Thyroid Medication
Timeline
| 12 Sep 2019 | Recall initiated by company | |
| 1 Oct 2019 | Classified by FDA | +19 days |
| 2 Oct 2019 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Product as listed by the FDA
Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02
Where it was distributed
Product was distributed throughout the United States.
Questions about this recall
Why was it recalled?
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Which lots are affected?
08569357, exp 4/30/2020; 07983652, 08544833, exp 6/30/2021
Where was it sold?
Product was distributed throughout the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 83792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide | |
| CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide | |
| CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |
More recalls from Shire Human Genetic Therapies
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |
| Drug | CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |
| Drug | CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |
| Drug | CLASS I | Vpriv¿ (velaglucerase alfa for injection) , Lyophilized Powder recalledVpriv | Shire Human Genetic Therapies | Particulate Matter | Nationwide |
Other Natpara (parathyroid Hormone recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |
| Drug | CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |
| Drug | CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |