Ascend Laboratories, LLC recalls Dabigatran etexilate Capsules
- Recalling company
- Ascend Laboratories, LLC
- Product
- Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
- 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.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Jun 30, 2026
- Reported
- Jul 29, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 2,717 cartons
- Lot / codes
- Lot: 25141584, Exp 4/30/2027.
- Company location
- Bedminster, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0736-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0736-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.