Ascend Laboratories recalls 150mg Dabigatran Etexilate Capsules (60-count) manufactured in India with potential impurities that could affect safety. This is a prescription drug.
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
Ascend Laboratories is recalling 150 mg Dabigatran Etexilate Capsules (60-count) because lab tests found impurities that could be unsafe. This is a prescription drug that requires a doctor's supervision.
The drug tests showed impurities that could be harmful. These impurities might affect how the medication works, potentially causing health risks for people taking blood thinners.
Prescription drug users who have the specific 150 mg Dabigatran Etexilate Capsules (60-count) manufactured by Alkem Laboratories Ltd. in India. People taking blood thinners need extra care.
Look for the 150 mg Dabigatran Etexilate Capsules in a 60-count blister pack with the lot number 25141583, expiring April 30, 2027. This product is only available by prescription.
Verify the product's lot number and expiration date to confirm if it's affected.
The official recall notice states that lab tests found impurities that could be unsafe, but it does not specify if the product is safe to use.
The recall notice does not mention any remedy or fix for this product.
The official recall notice does not specify who to contact for assistance.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0737-2026 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0737-2026 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.
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