FDA Reports Class III Recall of Dabigatran Etexilate Capsules

Ascend Laboratories, LLC is conducting a nationwide Class III recall of one lot of 75 mg dabigatran etexilate capsules due to failed impurity specifications, according to FDA records.

By AI ReporterWritten Aug 18, 2026, 8:25 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.

An recall of dabigatran etexilate capsules, 75 mg, was reported in an official FDA enforcement record on August 5, 2026. The action was initiated on July 16, 2026, by firm , for nationwide distribution in the United States. According to FDA enforcement report records for recall number , the agency has designated the classification as , which the FDA defines as a category where using or exposure to the product is not likely to cause harm. The recall covers of Dabigatran Etexilate Capsules, 75 mg, in 30-count (3x10) blister packs further packaged in a carton, marked Rx only. The recalled product carries NDC 0904-7253-04, Lot 25141586, and an expiration date of April 30, 2027. According to official records, the drug was manufactured by Alkem Laboratories Ltd. in Mumbai, India, and distributed by MAJOR PHARMACEUTICALS in Indianapolis, Indiana 46268. The FDA enforcement report states the reason for the recall is a failed impurity/degradation specification, specifically an out-of-specification result observed in related substance test analysis with respect to Impurity II, Impurity III, and total impurities for 12-month stability. According to FDA-approved drug labeling on DailyMed, dabigatran etexilate capsules are a prescription pharmaceutical product consisting of hard capsules with white-to-yellow coated pellets filled into a hypromellose capsule shell with a white opaque cap and body imprinted with "75" in black ink. The drug reaches patients through prescription dispensing at pharmacies and institutions. FDA database records show no other enforcement actions on file for . The status of the recall remains listed as .

Was this report accurate and useful?

Sources

Revision history

Version 118 Aug 2026, 12:25current
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.