Ascend Laboratories recalls Dabigatran Etexilate Capsules due to impurity risk
Ascend Laboratories recalls 75mg Dabigatran Etexilate capsules (NDC 0904-7253-68) due to failed impurity tests. This could affect drug safety for patients using blood thinners.
Recall notice
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
What happened, in plain English
Ascend Laboratories is recalling 75 mg Dabigatran Etexilate capsules because lab tests found unexpected impurities that could affect drug safety. This recall matters because blood thinners like this medication require precise chemical composition to work safely. Read more at govinfonow.com/recall/309278-ascend-laboratories-recalls-dabigatran-etexilate-capsules-due-to-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/309278-ascend-laboratories-recalls-dabigatran-etexilate-capsules-due-to-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0738-2026
Cite this page
“Ascend Laboratories recalls Dabigatran Etexilate Capsules due to impurity risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/309278-ascend-laboratories-recalls-dabigatran-etexilate-capsules-due-to-impurity-risk. Based on FDA recall #D-0738-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0738-2026%22&limit=1).
Why it’s dangerous
The medication was tested for impurities but failed a critical quality check. This means the capsules might contain harmful substances that could affect how the drug works in the body.
Who’s affected
Patients prescribed this blood thinner medication by a doctor are likely affected. Those with specific health conditions requiring careful blood thinners are at higher risk.
How to tell if you have this one
Check for the 75 mg Dabigatran Etexilate capsules in a 60-count blister pack with NDC 0904-7253-68. The product was manufactured by Alkem Laboratories Ltd. in Mumbai, India and distributed by Major Pharmaceuticals in Indianapolis.
- Brand
Ascend Laboratories- Category
Drug
All 3 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-0737-2026 | Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.; Lot: 25141583, Exp. April 30, 2027. | 3,600 cartons x 6 x 10 (in blister pack) |
| D-0738-2026 | Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.; Lot: 25141585, Exp. April 30, 2027. | 924 cartons x 12 x 6 x 10 (in blister pack) |
| D-0739-2026 | Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.; Lot: 25141586, Exp. April 30, 2027. | 936 cartons x 12 x 3 x 10 (in blister pack) |
What to do — step by step
Check Product Details
Look for the NDC code 0904-7253-68 on the packaging to confirm if this specific batch is affected.
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 20 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- 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-0738-2026 (July 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0738-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.