Dabigatran Etexilate recalls
Dabigatran Etexilate products have been recalled 9 times, most recently on 5 Aug 2026. The recalling company is usually Ascend Laboratories. The most common reason is potency & assay.
Total recalls9since 2023
Last 12 months5reported
Class I00% of total
Ongoing9latest 5 Aug 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 4 44%Class III 5 56%
Why dabigatran etexilate is recalled
Companies
Product types
By year
Ongoing dabigatran etexilate recalls
9 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dabigatran Etexilate Capsules, 150 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran etexilate Capsules, 110 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran etexilate Capsules, 150 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dabigatran Etexilate recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Nitrosamine Impurity | Nationwide |
All dabigatran etexilate recalls, newest first
9 totalAbout this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.