Ascend Dabigatran Capsules Recall: N-nitroso-dabigatran Impurity Risk

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Recalling firmAscend Laboratories, LLC339 Jefferson Rd Ste 101, N/A · Parsippany, NJ 07054-3707

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Ascend Laboratories is recalling certain Dabigatran Etexilate capsules due to detectable levels of N-nitroso-dabigatran impurities that exceed safe limits. This could pose a health risk to patients using these blood thinners.

Why it’s dangerous

The capsules contain N-nitroso-dabigatran impurities at levels above the acceptable daily intake limit. This impurity could potentially cause health issues when taken as directed.

Who’s affected

Patients prescribed Dabigatran Etexilate capsules by a doctor who received these specific lots from Ascend Laboratories in India. Those using the medication for blood thinning are most at risk.

How to tell if you have this one

Check the bottle for the lot numbers 22142462-22143002 and expiration dates of May 2024 or June 2024. The product is a prescription-only blood thinner.

Brand
Ascend Laboratories
Category
Drug

Based on the official FDA remedy

What to do — step by step

Contact Your Doctor
Your doctor can advise on whether to stop using the medication and what alternatives might be safe.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall record states the product has impurities above safe limits, so it is not safe to use as directed.

What should I do if I have these capsules?

The recall record does not specify a remedy, so contact your doctor for guidance.

How can I tell if I have the recalled product?

Check for lot numbers 22142462-22143002 with expiration dates of May 2024 or June 2024.

Take action

Contact Ascend Laboratories

We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0533-2023 — Ascend Laboratories Ascend Laboratories

Hello,

I own a Ascend Laboratories that is covered by recall D-0533-2023 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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Where this comes from

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.

Official source: FDA Recall #D-0533-2023 (March 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0533-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA,

Recall notice