Ascend Laboratories recalls 150mg Dabigatran Etexilate capsules (NDC 67877-475-60) due to presence of N-nitroso-Dabigatran impurity above safety limits. Rx only, manufactured in India, distributed in US.
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Ascend Laboratories is recalling 150mg Dabigatran Etexilate capsules (60-count bottles) because they contain a harmful impurity that could pose health risks. This is a prescription-only medication distributed in the US, and affected units were manufactured in India.
The capsules contain N-nitroso-Dabigatran impurity levels above the recommended safety threshold. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
Prescription patients using Dabigatran Etexilate 150mg capsules with specific lot numbers and expiration dates. Those with the medication in their possession are most at risk.
Check for the product name 'Dabigatran Etexilate 150mg capsules', 60-count bottles, Rx only. Look for lot numbers 24142192, 24142193, 24142194 (expiring April 30, 2026) or 24142463 (expiring May 31, 2026).
Verify the lot number and expiration date on the capsule packaging to confirm if it's affected.
The recall states the presence of an impurity above safety limits, but does not specify if the medication is safe to use. Consult your doctor for guidance.
The recall does not provide specific action steps for affected users. Contact your doctor or the manufacturer for instructions.
Check the lot numbers: 24142192, 24142193, 24142194 (expiring April 30, 2026) or 24142463 (expiring May 31, 2026).
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0130-2025 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0130-2025 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.
