Dabigatran Etexilate Capsules, 75 mg recall — Ascend Laboratories, LLC (Class III)

Regulatory snapshot

Reason reported by FDA

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

23 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

7 identifying values matched by exact pattern in the 31-word product description above; each is a literal substring of it.

Which configuration this record is

3 recall numbers share event 99421. They differ on strength, package and ndc and agree on everything else the source states, so those are the values to check a package against.

Shared across all 3 records under this event: form Capsules; product named Dabigatran Etexilate Capsules; fda tier Class III; recalling firm Ascend Laboratories, LLC; the same reason text; initiated 2026-07-16; reported 2026-08-05.

Reading this record

Class III is the FDA's own severity tier for the recall action — 25 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 99421 returns all 3 of these recall numbers; a search on D-0738-2026 returns only this configuration. Match a package against 0904-7253-68 at the FDA source to confirm it is covered.

Namespace context: the Class III index (25 records) and the recall hub (250 records, 118 FDA events); Ascend Laboratories, LLC (9 indexed records) aggregates this firm across datasets.

• What "Ongoing" recall status means
• How to search FDA drug recalls by NDC
• How to monitor a manufacturer’s recall history
• FDA recall classifications: Class I, II and III

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0738-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.