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.
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 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.
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.
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.
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.
Look for the NDC code 0904-7253-68 on the packaging to confirm if this specific batch is affected.
The recall is due to failed impurity tests, but the official notice doesn't specify if the medication is dangerous in normal use.
Check for the NDC code 0904-7253-68 on the packaging. The product was manufactured by Alkem Laboratories Ltd. in Mumbai, India and distributed by Major Pharmaceuticals in Indianapolis.
The recall notice doesn't provide specific action steps for affected patients.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0738-2026 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0738-2026 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.
