Ascend Laboratories recalls 75mg Dabigatran Etexilate capsules (NDC 67877-474-60) manufactured by Alkem Labs in India. The capsules contain N-nitroso-Dabigatran impurity above safety limits, potentially causing health risks.
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Ascend Laboratories is recalling 75mg Dabigatran Etexilate capsules (60-count bottles) due to a chemical impurity that may pose health risks. This recall affects prescription-only medication sold in the U.S. from specific manufacturing lots.
The capsules contain N-nitroso-Dabigatran impurity levels above the recommended safety limit. This impurity could potentially cause health issues, though the exact risk level is not specified in the recall notice.
Prescription patients who have received the recalled capsules (NDC 67877-474-60, lots 24142328-24142330) from Ascend Laboratories. Those with specific medical conditions requiring blood thinners are most at risk.
Check for the product name 'Dabigatran Etexilate 75 mg capsules', 60-count bottles, prescription-only, with NDC 67877-474-60. The lot numbers are 24142328, 24142329, or 24142330, expiring May 31, 2026.
Identify the NDC number 67877-474-60 and lot numbers 24142328-24142330 on the packaging.
Talk to your doctor or pharmacist about whether you have the recalled capsules and what to do next.
The recall states the capsules contain N-nitroso-Dabigatran impurity above safety limits, but the exact health risk is not specified. Consult your healthcare provider.
The recall does not provide specific disposal or return instructions. Contact your healthcare provider for guidance.
Check for NDC 67877-474-60, lot numbers 24142328-24142330, and expiration date May 31, 2026 on the packaging.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0129-2025 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0129-2025 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.
