Ascend Laboratories recalls Dabigatran Etexilate capsules with potential impurity risk
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.
Recall notice
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/32367-ascend-laboratories-recalls-dabigatran-etexilate-capsules-with-potential-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32367-ascend-laboratories-recalls-dabigatran-etexilate-capsules-with-potential-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0130-2025
Cite this page
“Ascend Laboratories recalls Dabigatran Etexilate capsules with potential impurity risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32367-ascend-laboratories-recalls-dabigatran-etexilate-capsules-with-potential-impurity-risk. Based on FDA recall #D-0130-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0130-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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).
- Brand
Ascend Laboratories- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide within the United States- NDC
67877-475-60, 67877-474-60, 67877-624-60, 67877-624-31
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0129-2025 | Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60; Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026. | 1971 bottles |
| D-0130-2025 | Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60; Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026; | 10,444 bottles |
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the capsule packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 6 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0130-2025 (December 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0130-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.