Ascend Laboratories, LLC Recalls

All product recalls associated with Ascend Laboratories, LLC.

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Recall Summary

Total Recalls

41

Past Year

10

Class I (Serious)

0

Most Recent

Sep 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 1–20 of 41 recalls

Atorvastatin Tablets 10mg (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDASep 19, 2025Nationwide• Ascend Laboratories, LLC

Atorvastatin Tablets 80mg (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDASep 19, 2025Nationwide• Ascend Laboratories, LLC

Atorvastatin Tablets 40mg (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDA

Sep 19, 2025

Nationwide

• Ascend Laboratories, LLC

Atorvastatin Tablets 20mg (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDASep 19, 2025Nationwide• Ascend Laboratories, LLC

Aripiprazole Tablets (Ascend) – Superpotent drug risk (2025)

Superpotent drug

Class IIModerate

FDAAug 28, 2025Nationwide• Ascend Laboratories, LLC

Amlodipine Olmesartan Tablets (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications: low dissolution results

Class IIModerate

FDAJul 21, 2025Nationwide• Ascend Laboratories, LLC

Rizatriptan Tablets (Ascend Laboratories) – Impurity Detection (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Rizatriptan Benzoate Tablets (Ascend) – CGMP Impurity (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Cephalexin Suspension (Ascend) - Stability Specification Failure (2025)

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

Class IIModerate

FDAMay 23, 2025Nationwide• Ascend Laboratories, LLC

Cephalexin Suspension (Ascend) - Stability Specification Failure (2025)

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

Class IIModerate

FDAMay 23, 2025Nationwide• Ascend Laboratories, LLC