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ASEGUA THERAPEUTICS LLC

ASEGUA THERAPEUTICS LLC Recalls

All product recalls associated with ASEGUA THERAPEUTICS LLC.

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Recall Summary

Total Recalls

1000

Past Year

304

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 261–280 of 4747 recalls

Sofosbuvir and Velpatasvir (ASEGUA) – Defective Container (2025)

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

Class IIModerate

FDAMar 7, 2025Nationwide• ASEGUA THERAPEUTICS LLC

Pacific Hemostasis Thromboplastin-D (Fisher Diagnostics) – Incorrect ISI Label (2025)

The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

FDAMar 6, 2025PA• Fisher Diagnostics

ID NOW Influenza A/B Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

FDAMar 4, 2025

1...12 131415 16...238

Page 14 of 238Next

Nationwide

• Abbott Diagnostics Scarborough, Inc.

ID NOW COVID-19 Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

ID NOW RSV Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)

Cross Contamination

Class IIILow

FDAMar 4, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)

Cross Contamination

Class IIILow

FDAMar 4, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Tolterodine Tartrate (Major Pharmaceuticals) – Dissolution Failure (2025)

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

Class IIILow

FDAMar 4, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Duloxetine Capsules 20mg (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Carvedilol Tablets 25mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Duloxetine Capsules 60mg (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Carvedilol Tablets 12.5mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 3.125mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Duloxetine Capsules 30mg (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Carvedilol Tablets 6.25mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

FilmArra Pneumonia Panel (BioFire) – Test Result Reliability (2025)

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

FDAFeb 27, 2025Nationwide• BioFire Diagnostics, LLC

Prasugrel Tablets 5mg (Mylan) – Dissolution Failure (2025)

Failed Dissolution Specifications - low dissolution results

Class IIModerate

FDAFeb 25, 2025Nationwide• MYLAN PHARMACEUTICALS INC

Livalo 4mg (Kowa) – Foreign Tablets (2025)

Presence of foreign tablets/capsules

Class IIILow

FDAFeb 24, 2025OH, PA, TX• Kowa Pharmaceuticals America

Zapzyt Acne Treatment Gel (Denison) – Benzene Contamination (2025)

Chemical Contamination: Presence of benzene.

Class IIModerate

FDAFeb 24, 2025Nationwide• Denison Pharmaceuticals, LLC

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc