Ascend Laboratories recalls 75mg Dabigatran Etexilate Capsules (30-count) with impurity issues that could affect safety. Consumers should check product details and contact the manufacturer.
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 75 mg Dabigatran Etexilate Capsules due to impurity issues found in stability testing. This could pose a safety risk if the medication is taken as intended.
The medication failed stability testing for impurities, which could mean the capsules contain harmful substances that might affect safety when taken. This is a quality issue that could lead to unintended health effects if the medication is used without proper testing.
People who have the specific 75 mg Dabigatran Etexilate Capsules (30-count) with the lot number 25141586, manufactured by Alkem Laboratories Ltd. in India and distributed by Major Pharmaceuticals in the U.S. are affected.
Check for the product name 'Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack' with the lot number 25141586, manufactured by Alkem Laboratories Ltd. in India.
Look for the lot number 25141586 on the packaging to confirm if the product is affected.
The recall indicates potential impurity issues that could affect safety, but the official notice does not specify if it is safe to take.
The official recall notice does not provide a remedy, so contact Ascend Laboratories for further instructions.
Check the lot number on the packaging; affected products have lot number 25141586.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0739-2026 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0739-2026 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.
