Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Dabigatran etexilate Capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
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.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
0904-7254-68
Compare with the code on your package — it is the most precise check available.
Drug: Dabigatran
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Dabigatran Etexilate NDC 00904-7254 |
MESYLATE 110 mg/1 | Capsule, Coated Pellets Oral |
Major Pharmaceuticals | Rx |
- Recalling firm
- Ascend Laboratories, LLC
- NDC code
- 0904-7254-68
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0735-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Dabigatran recalls
See all
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Dabigatran etexilate Capsules
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.
Class II · Moderate risk
Dabigatran Etexilate
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Other recalls by Ascend Laboratories, LLC
All 2026 recalls
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
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