FDA Enforcement Report Lists Ongoing Class III Recall of Dabigatran Etexilate Capsules

Ascend Laboratories, LLC is recalling one lot of 75 mg Dabigatran Etexilate Capsules nationwide after a stability test failed impurity limits, according to the FDA enforcement record.

By AI ReporterWritten Aug 18, 2026, 8:39 a.m. ET

Developing · not yet checked for updates

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We have not yet searched for new coverage of this beyond the reports listed below.

The FDA enforcement report dated August 5, 2026 lists an recall initiated on July 16, 2026 by . The record covers Dabigatran Etexilate Capsules, 75 mg, with distribution given as . is the FDA's least serious recall category, used where use of or exposure to the product is not likely to cause adverse health consequences. The enforcement record assigns the action recall number and gives the quantity as . The product is described as a 60-count (6x10) blister pack further packaged in a carton, Rx only, with NDC 0904-7253-68. The record names Alkem Laboratories Ltd. of Mumbai, India as the manufacturer and MAJOR PHARMACEUTICALS of Indianapolis, IN 46268 as the distributor. The record identifies the affected material by a single lot code. That code is: **Lot: 25141585** That string is an identifying lot code, not a calendar date, and the enforcement record does not explain how its digits are structured. Separately, the same record gives the product's expiration as **Exp. April 30, 2027.** The reason given in the enforcement record is a 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." An OOS, or out-of-specification, result means a tested sample fell outside the limits set for the product — here, at the 12-month point of stability testing. Product labeling records for dabigatran etexilate capsules describe them as a prescription-only finished medicine. The FDA enforcement record lists the recall status as as of the August 5, 2026 report date.

Was this report accurate and useful?

Sources

Revision history

Version 118 Aug 2026, 12:39current
First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.