Ascend Laboratories, LLC

32 FDA enforcement actions

32 Total Recalls

0 Class I

30 Class II

2 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 09/19/2025 drug

Failed Dissolution Specifications
Class II: Risk 09/19/2025 drug

Failed Dissolution Specifications
Class II: Risk 09/19/2025 drug

Failed Dissolution Specifications
Class II: Risk 09/19/2025 drug

Failed Dissolution Specifications
Class II: Risk 08/28/2025 drug

Superpotent drug
Class II: Risk 07/21/2025 drug

Failed Dissolution Specifications: low dissolution results
Class II: Risk 07/09/2025 drug

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II: Risk 07/09/2025 drug

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II: Risk 05/23/2025 drug

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 II: Risk 05/23/2025 drug

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 II: Risk 12/12/2024 drug

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II: Risk 12/12/2024 drug

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II: Risk 09/03/2024 drug

Failed Dissolution Specifications
Class II: Risk 01/16/2024 drug

Failed Impurities/Degradation Specification: Out of specification for organic impurities
Class II: Risk 12/29/2023 drug

Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class III: Low Risk 07/18/2023 drug

Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Class II: Risk 07/11/2023 drug

Failed Dissolution Specifications
Class II: Risk 03/17/2023 drug

Out of specification (OOS) for Spectroscopic Identification test by IR.
Class II: Risk 03/14/2023 drug

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II: Risk 03/14/2023 drug

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II: Risk 01/05/2023 drug

Failed Dissolution Specification
Class II: Risk 01/05/2023 drug

Failed Dissolution Specification
Class II: Risk 01/05/2023 drug

Failed Dissolution Specification
Class II: Risk 12/28/2022 drug

Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Class II: Risk 01/12/2022 drug

Failed Dissolution Specifications.
Class II: Risk 12/21/2021 drug

Failed impurities/degradation specifications
Class II: Risk 11/03/2021 drug

Failed Impurities/Degradation Specifications
Class III: Low Risk 04/29/2021 drug

Presence of Foreign Tablet/Capsule
Class II: Risk 01/22/2021 drug

CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class II: Risk 01/22/2021 drug

CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class II: Risk 12/17/2020 drug

Failed Impurity/Degradation Specifications
Class II: Risk 12/17/2020 drug

Failed Impurity/Degradation Specifications

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.