Ascend Laboratories, Llc: Dabigatran Etexilate Capsules, 110 Mg, 60-count Carton (6x10)
Recall Summary Ascend Laboratories is recalling Dabigatran etexilate 110 mg capsules (60-count cartons) distributed in the U.S. because testing found the medication failed to meet purity standards during stability testing, with higher-than-acceptable levels of impurities detected at the 12-month mark. This blood thinner medication was manufactured by Alkem Laboratories in India and distributed by Major Pharmaceuticals. The recall affects patients who may have received affected batches of this prescription blood clot prevention drug.
- Recalling firm
- Ascend Laboratories, LLC
- Product
- Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
- Reason
- Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-30
- Status
- Ongoing
- Distribution
- Within the U.S Market
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/b2f62a94-a597-4754-afa2-77cadba16ae9