Ascend Dabigatran Etexilate 150mg Capsules Recall: N-nitroso Impurity Risk
Ascend Laboratories recalls 150mg Dabigatran Etexilate capsules (NDC 67877-475-60) due to detected N-nitroso-dabigatran impurities exceeding safety limits. Affected lots expire May 2024 or July 2024.
Recall notice
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Contact the company
What happened, in plain English
Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules that were manufactured with N-nitroso-dabigatran impurities above safe levels. This could cause serious health risks if taken as prescribed. Read more at govinfonow.com/recall/33807-ascend-dabigatran-etexilate-150mg-capsules-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33807-ascend-dabigatran-etexilate-150mg-capsules-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0534-2023
Cite this page
“Ascend Dabigatran Etexilate 150mg Capsules Recall: N-nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33807-ascend-dabigatran-etexilate-150mg-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0534-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0534-2023%22&limit=1).
Why it’s dangerous
The capsules contained N-nitroso-dabigatran impurities at levels above the acceptable daily intake limit. This impurity could potentially cause serious health effects when taken as prescribed.
Who’s affected
Prescription drug users who purchased the specific lots of Dabigatran Etexilate capsules from Ascend Laboratories in the US. People taking blood thinners are most at risk.
How to tell if you have this one
Check for the product name 'Dabigigatran Etexilate 150mg Capsules', 60-count bottles, and lot numbers 22142448-22142450 (expiring May 2024) or 22143845 (expiring July 2024).
- 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 in the USA.- NDC
67877-475-60, 67877-474-60, 67877-624-60, 67877-624-31
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0533-2023 | Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.; Lot #s: 22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024. | 13,560 bottles |
| D-0534-2023 | Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.; Lot #s: 22142448, 22142449, 22142450, Exp 5/2024; 22143845, Exp 7/2024. | 12,804 bottles |
What to do — step by step
Check Product Details
Look for the lot numbers 22142448-22142450 (expiring May 2024) or 22143845 (expiring July 2024) on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 22 days after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Ascend Laboratories recalls
Latest drug recalls
Keep exploring
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-0534-2023 (March 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0534-2023 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.