Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dabigatran Etexilate Recalled by Ascend Laboratories, LLC Due to CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended...
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, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60
Quantity: 10,444 bottles
Why Was This Recalled?
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim 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