Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dabigatran Etexilate 150mg Capsules Recalled by Ascend Laboratories, LLC Due to CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ascend Laboratories, LLC directly.
Affected Products
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.
Quantity: 12,804 bottles
Why Was This Recalled?
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ascend Laboratories, LLC
Ascend Laboratories, LLC has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report