Dabigatran Etexilate recalls
The FDA has published 9 recalls involving Dabigatran Etexilate since 2023. The latest was reported on 5 Aug 2026. Most were for potency & assay. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
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
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 totalShould you stop taking Dabigatran Etexilate?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.