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Noven Therapeutics, LLC

Noven Therapeutics, LLC Recalls

All product recalls associated with Noven Therapeutics, LLC.

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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 1681–1700 of 4747 recalls

Daytrana Patches (Noven) – Delivery System Defect (2020)

Defective Delivery System: Out of specification for mechanical peel and shear.

Class IIModerate

FDAMar 2, 2020Nationwide• Noven Therapeutics, LLC

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer, Siemens Material Number 1106700...

Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.

FDAFeb 27, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Zoledronic Acid Injection (Breckenridge) – Impurity Specs (2020)

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.

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Class IIILow

FDAFeb 24, 2020Nationwide• Breckenridge Pharmaceutical, Inc

Mesalamine Tablets (Teva) – Dissolution Specification Failure (2020)

Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.

Class IIModerate

FDAFeb 20, 2020Nationwide• Teva Pharmaceuticals USA

Desoximetasone Topical Spray (Lupin) – Impurity Specification Failure (2020)

Failed Impurities/Degradation Specification; high out of specification results observed

Class IIModerate

FDAFeb 19, 2020Nationwide• Lupin Pharmaceuticals Inc.

Haemonetics Corporation: TEG Manager software versions used in conjunction with TE...

Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa.

FDAFeb 19, 2020Nationwide• Haemonetics Corporation

Siemens Healthcare Diagnostics, Inc.: Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Materi...

The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.

FDAFeb 14, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Micro Therapeutics Inc, Dba Ev3 Neurovascular: ev3 Pipeline Flex Embolization Device. For neurological ...

Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.

FDAFeb 14, 2020Nationwide• Micro Therapeutics Inc, Dba Ev3 Neurovascular

Fexofenadine Tablets (Discount Drug Mart) – Labeling Error (2020)

Labeling: Incorrect or Missing Lot and/or Expiration date.

Class IIILow

FDAFeb 14, 2020OH• AAA Pharmaceutical, Inc.