Has Ascend Laboratories, LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 10 total FDA actions tied to Ascend Laboratories, LLC: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged medium severity by Argus HQ. FDA published the underlying record on 2026-08-05; Argus observed and indexed it on 2026-08-19.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · drug_recall · medium

Ascend Laboratories, LLC — Class III recall: Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packag…

Name: FDA Recall Record — Ascend Laboratories, LLC
Creator: Argus HQ
Published: 2026-08-05
License: https://argushq.ai/methodology

Event date: 2026-08-05 00:00:00Z
Observed: 2026-08-19 04:20:35Z
Source ID: D-0738-2026
Payload hash: 0218a9cb6497baf78f56cda2…

Summary

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability Status: Ongoing.

Entities

Ascend Laboratories, LLC

View source record ↗

Frequently asked questions

Has Ascend Laboratories, LLC had other FDA enforcement actions?: Yes. Argus HQ has recorded 10 total FDA actions tied to Ascend Laboratories, LLC: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged medium severity by Argus HQ. FDA published the underlying record on 2026-08-05; Argus observed and indexed it on 2026-08-19.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Ascend Laboratories, LLC — Class III recall: Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packag…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-ascend-laboratories-llc-d-0738-2026

MLA

"Ascend Laboratories, LLC — Class III recall: Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packag…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-ascend-laboratories-llc-d-0738-2026.

Chicago

Argus HQ Research. "Ascend Laboratories, LLC — Class III recall: Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packag…." Digital Empire Holdings LLC. Accessed August 19, 2026. https://argushq.ai/events/fda-recall-ascend-laboratories-llc-d-0738-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_ascend_laboratories_llc_d_0738_2026_2026,
  title = {Ascend Laboratories, LLC — Class III recall: Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packag…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-ascend-laboratories-llc-d-0738-2026},
  note = {Accessed: August 19, 2026}
}

Informational only. Not legal, financial, or medical advice.