Ascend Laboratories recalls Dabigatran etexilate capsules due to impurity risks
Ascend Laboratories recalls 150mg Dabigatran etexilate capsules (NDC 0904-7255-10) manufactured by Alkem Laboratories in India. The capsules failed impurity tests during stability testing, potentially posing health risks.
Recall notice
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.
What happened, in plain English
Ascend Laboratories is recalling 150 mg Dabigatran etexilate capsules (20-count) that were manufactured by Alkem Laboratories in India. The capsules failed impurity tests during stability testing, which could pose health risks to patients taking these blood thinners. Read more at govinfonow.com/recall/164231-ascend-laboratories-recalls-dabigatran-etexilate-capsules-due-to-impurity-risks.
Source Summary by GovInfoNow · govinfonow.com/recall/164231-ascend-laboratories-recalls-dabigatran-etexilate-capsules-due-to-impurity-risks · Updated August 17, 2026 · FDA enforcement record: FDA #D-0736-2026
Cite this page
“Ascend Laboratories recalls Dabigatran etexilate capsules due to impurity risks.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/164231-ascend-laboratories-recalls-dabigatran-etexilate-capsules-due-to-impurity-risks. Based on FDA recall #D-0736-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0736-2026%22&limit=1).
Why it’s dangerous
The capsules failed impurity tests during long-term stability testing, indicating potential chemical breakdown that could affect the medication's safety and effectiveness. This could lead to improper blood clotting control in patients taking the drug.
Who’s affected
Patients prescribed Dabigatran etexilate capsules by a doctor who received this specific batch (lot 25141584) from the manufacturer. Those with blood clotting conditions or on anticoagulant therapy are most at risk.
How to tell if you have this one
Check for the product name 'Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10)' with lot number 25141584. The capsules were distributed by Major Pharmaceuticals in Indianapolis, Indiana, with an expiration date of April 30, 2027.
- Brand
Ascend Laboratories- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Ongoing- Distribution
USA Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0735-2026 | Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.; Lot: 25141707, Exp 4/30/2027. | 1,753 cartons |
| D-0736-2026 | Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.; Lot: 25141584, Exp 4/30/2027. | 2,717 cartons |
What to do — step by step
Check Product Details
Verify the lot number on the packaging to confirm if your capsules are affected (lot 25141584).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class III
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0736-2026 (June 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0736-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.