LowFDAOngoing
Unlikely to harm you, but it breaks the rules. Your pharmacist can tell you more.
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.
Check the label for
Lot: 25141707, Exp 4/30/2027.
- Why
- 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.
- Distributed
- USA Nationwide
- Company
- Ascend Laboratories, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Already ate or took it and feel unwell? Call Poison Control — 1-800-222-1222
Source: FDA record D-0735-2026 · retrieved 4 August 2026
Read the official notice