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.
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.
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.
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.
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.
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.
Verify the lot number on the packaging to confirm if your capsules are affected (lot 25141584).
The capsules failed impurity tests during long-term stability testing, indicating potential chemical breakdown that could affect safety and effectiveness.
The recall record does not specify a remedy, so contact your doctor or pharmacist for guidance.
The recall record does not specify if the medication is safe; consult your healthcare provider for personalized advice.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0736-2026 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0736-2026 from Ascend Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
