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Manufacturer profile

Ascend Laboratories, LLC

Pharmaceutical company6 products tracked
6
products tracked
438,973
total reports
217
recalls on record
77.1%
serious overall
Products
showing 6 of 6
ProductApprovedReports ↓Top signalRecalls
1986190,113Drug dependence100
1986119,783Drug dependence100
201986,447Central nervous system lesion1
201223,718Multiple-drug resistance7
—14,129Chronic kidney disease9
20104,783Expanded disability status scale score increased0
Recall history · 50 on record
DateClassReasonFirm
Jun 1, 2026IIFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysisAscend Laboratories, LLC
May 5, 2026IIFailed Dissolution Specifications: Olmesartan Medoxomil content below specificationsAscend Laboratories, LLC
Apr 27, 2026IIFailed Dissolution SpecificationsAscend Laboratories, LLC
Nov 26, 2025IIICorrect Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.Winder Laboratories, LLC
Sep 19, 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
Sep 19, 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
Sep 19, 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
Sep 19, 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
Aug 28, 2025IISuperpotent drugAscend Laboratories, LLC
Jul 21, 2025IIFailed Dissolution Specifications: low dissolution resultsAscend Laboratories, LLC
Jul 9, 2025IICGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.Ascend Laboratories, LLC
Jul 9, 2025IICGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.Ascend Laboratories, LLC
May 23, 2025IIFailed 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.Ascend Laboratories, LLC
May 23, 2025IIFailed 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.Ascend Laboratories, LLC
Feb 17, 2025IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.Safecor Health, LLC
Feb 6, 2025IIFailed Dissolution SpecificationsSUN PHARMACEUTICAL INDUSTRIES INC
Jan 7, 2025IIPresence of Foreign Tablets/CapsulesAmerisource Health Services LLC
Dec 13, 2024IIPresence of Foreign Tablets/CapsulesAmerisource Health Services LLC
Dec 12, 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
Dec 12, 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
Oct 22, 2024IIFailed Impurities/Degradation SpecificationDr. Reddy's Laboratories, Inc.
Sep 3, 2024IIFailed Dissolution SpecificationsAscend Laboratories, LLC
Mar 12, 2024IIThe filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.Hikma Pharmaceuticals USA Inc.
Feb 12, 2024IICGMP Deviations: Out of specification for residual solvents.Micro Labs Limited
Dec 29, 2023IIPresence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.Ascend Laboratories, LLC
Jul 17, 2023IILack of assurance of sterility: Lack of validation data for sanitization cyclesCentral Admixture Pharmacy Services Inc
Jul 17, 2023IILack of assurance of sterility: Lack of validation data for sanitization cyclesCentral Admixture Pharmacy Services Inc
Jul 11, 2023IIFailed Dissolution SpecificationsAscend Laboratories, LLC
Mar 17, 2023IIOut of specification (OOS) for Spectroscopic Identification test by IR.Ascend Laboratories, LLC
Mar 14, 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
Mar 14, 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
Mar 2, 2023IICGMP Deviations: Potential risk of Cross ContaminationBreckenridge Pharmaceutical, Inc
Mar 2, 2023IICGMP Deviations: Potential risk of Cross ContaminationBreckenridge Pharmaceutical, Inc
Jan 5, 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
Jan 5, 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
Jan 5, 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
Dec 28, 2022IIPresence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.Ascend Laboratories, LLC
Dec 27, 2022IILack of sterility assuranceSentara Infusion Services
Jun 17, 2022ILabeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.Bryant Ranch Prepack, Inc.
Jun 17, 2022ILabeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.Bryant Ranch Prepack, Inc.
Jan 12, 2022IIFailed Dissolution Specifications.Ascend Laboratories, LLC
Jan 7, 2022IIFailed Stability SpecificationsVistaPharm, Inc.
Dec 21, 2021IIFailed impurities/degradation specificationsAscend Laboratories, LLC
Dec 3, 2021IIILabeling: Missing LabelAkorn, Inc.
Nov 12, 2021IILack of Assurance of SterilitySterRx, LLC
Sep 17, 2021IIDefective container: Cracked vials leading to lack of sterility assuranceFresenius Kabi USA LLC
Dec 17, 2020IIILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
Dec 17, 2020IILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
Dec 17, 2020IILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
Aug 6, 2020IILack of Assurance of SterilityFamily Pharmacy of Statesville

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from Ascend Laboratories, LLC are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.