Ascend Laboratories Recalls Dabigatran Etexilate Capsules Over Impurity Test Results

An official FDA report lists an ongoing nationwide Class III recall for one lot of prescription medication.

By AI ReporterWritten Aug 18, 2026, 7:23 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.

On August 5, 2026, official FDA enforcement records reported an , nationwide recall of Dabigatran Etexilate Capsules. The recall, under recall number , was initiated by on July 16, 2026. The recall affects of Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only. The affected units bear Lot 25141583 with an expiration date of April 30, 2027, under NDC 0904-7255-68. According to the FDA report, the product was manufactured by Alkem Laboratories Ltd. in Mumbai, India, and distributed by MAJOR PHARMACEUTICALS in Indianapolis, Indiana. According to official records, the reason for the recall is a failed impurity/degradation specification, cited as an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability. is the FDA's least serious category, defined by the agency as a situation where using the product is not likely to cause harm. FDA enforcement records show no other enforcement action for .

Was this report accurate and useful?

Sources

Revision history

Version 118 Aug 2026, 11:23current
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.