FDAFDA recall D-0735-2026 · Jul 29, 2026
Ascend Laboratories, LLC: Dabigatran etexilate Capsules recall
Recall found
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 for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class III: use of or exposure to the product is not likely to cause health problems.
- Status
- Ongoing
- Codes, lots and dates
- Lot: 25141707, Exp 4/30/2027.
- Quantity
- 1,753 cartons
- Distribution
- USA Nationwide
- Recalling firm
- Ascend Laboratories, LLC, Bedminster, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-30
Source: openFDA enforcement record D-0735-2026 · search recall number D-0735-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 31, 2026, 6:32 AM EDT. The agency notice is the final word.