Natpara 25 mcg (Shire) – Delivery System Defect (2019)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Shire Human Genetic Therapies, Inc.
Lot Codes / Batch Numbers
08569357, exp 4/30/2020, 07983652, 08544833, exp 6/30/2021
Products Sold
08569357, exp 4/30/2020; 07983652, 08544833, exp 6/30/2021
Shire Human Genetic Therapies, Inc. is recalling Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneo due to Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026