Skip to main content

fda_recall · drug_recall · medium

Ascend Laboratories, LLC — Class III recall: Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufact…

Event date
2026-07-29 00:00:00Z
Observed
2026-08-12 04:20:18Z
Source ID
D-0735-2026
Payload hash
e7fa40a1c1908b5d5be9d172…

Summary

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Ascend Laboratories, LLC had other FDA enforcement actions?
Yes. Argus HQ has recorded 7 total FDA actions tied to Ascend Laboratories, LLC: 0 warning letters, 7 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 2026-07-29; Argus observed and indexed it on 2026-08-12.
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, 110 mg, 60-count carton (6x10), Rx Only, Manufact…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-ascend-laboratories-llc-d-0735-2026
MLA
"Ascend Laboratories, LLC — Class III recall: Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufact…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-ascend-laboratories-llc-d-0735-2026.
Chicago
Argus HQ Research. "Ascend Laboratories, LLC — Class III recall: Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufact…." Digital Empire Holdings LLC. Accessed August 13, 2026. https://argushq.ai/events/fda-recall-ascend-laboratories-llc-d-0735-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_ascend_laboratories_llc_d_0735_2026_2026,
  title = {Ascend Laboratories, LLC — Class III recall: Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufact…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-ascend-laboratories-llc-d-0735-2026},
  note = {Accessed: August 13, 2026}
}

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

Ascend Laboratories, LLC — Class III recall: Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufact… · Argus HQ