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Shire Human Genetic Therapies, Inc.

Shire Human Genetic Therapies, Inc. Recalls

All product recalls associated with Shire Human Genetic Therapies, Inc..

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1881–1900 of 4747 recalls

Natpara 25 mcg (Shire) – Delivery System Defect (2019)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Class IHigh

FDASep 12, 2019Nationwide• Shire Human Genetic Therapies, Inc.

Natpara 100 mcg (Shire) – Delivery System Risk (2019)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Class IHigh

FDASep 12, 2019Nationwide• Shire Human Genetic Therapies, Inc.

Natpara Injection (Shire) – Delivery System Defect (2019)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

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Class I

High

FDASep 12, 2019Nationwide• Shire Human Genetic Therapies, Inc.

Natpara Injection (Shire) – Delivery System Defect (2019)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Class IHigh

FDASep 12, 2019Nationwide• Shire Human Genetic Therapies, Inc.

Roche Diagnostics Operations, Inc.: Cobas c Bilirubin Total Gen.3 Catalog Number: 0579541919...

Due to low Quality Control recovery and invalid Calibration.

FDASep 11, 2019Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Nu...

Due to low Quality Control recovery and invalid Calibration.

FDASep 11, 2019Nationwide• Roche Diagnostics Operations, Inc.

Ortho-Clinical Diagnostics: VITROS chemistry Products Cl- Slides, Catalog No. 6844471...

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

FDASep 10, 2019Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS chemistry Products K+ Slides, Catalog No. 8157596....

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

FDASep 10, 2019Nationwide• Ortho-Clinical Diagnostics

Nucala (Cardinal Health) - temperature storage issue (2019)

Temperature Abuse; Product stored and shipped outside of labeled storage requirements.

Class IIModerate

FDASep 6, 2019Nationwide• Cardinal Health dba Specialty Pharmaceutical Services

Matzim LA Tablets (Teva) - distribution deviation (2019)

GMP Deviation: lot not intended for commercial distribution.

Class IIILow

FDASep 6, 2019Nationwide• Teva Pharmaceuticals USA

Gatifloxacin Eye Solution (Mylan) - impurity specification (2019)

Failed Impurities/Degradation Specifications:OOS for unknown impurity.

Class IIILow

FDASep 6, 2019Nationwide• Mylan Pharmaceuticals Inc.

Pantoprazole Tablets (Jubilant) - tablet discoloration (2019)

CGMP Deviation: Presence of dark brown discoloration on edges of tablets.

Class IIModerate

FDASep 4, 2019MS, OH, RI +2 more• Jubilant Cadista Pharmaceuticals, Inc.

Fexofenadine Tablets (Preferred Pharmaceuticals) – Impurity Failure (2019)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAAug 29, 2019FL, IN• Preferred Pharmaceuticals, Inc

Roche Diagnostics Operations, Inc.: cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus ...

Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference

FDAAug 28, 2019Nationwide• Roche Diagnostics Operations, Inc.

Ascorbic Acid Injection (Atlas Pharmaceuticals) – Mislabeling (2019)

Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.

Class IIModerate

FDAAug 28, 2019AZ, CO, IN• Atlas Pharmaceuticals, LLC

Roche Diagnostics Operations, Inc.: cobas c 701 and 702 Analyzer/Module-RF interference claim...

Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference

FDAAug 28, 2019Nationwide• Roche Diagnostics Operations, Inc.

RESPIRATORY THERAPEUTICS GROUP LLC: RespVent Closed Suction System T-Piece Tracheostomy Adult...

It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.

FDAAug 19, 2019Nationwide• RESPIRATORY THERAPEUTICS GROUP LLC

Ketamine Injection (SCA) – Sterility Concern (2019)

Lack of Assurance of Sterility.

Class IIModerate

FDAAug 16, 2019Nationwide• SCA Pharmaceuticals, LLC

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19...

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

FDAAug 15, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.1...

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

FDAAug 15, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.