Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Dabigatran recalled?

Yes — there is an active recall. 9 ongoing FDA recalls mention Dabigatran (10 total). Check the affected lots below.

Most common reason: Impurity / degradation (5 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Dabigatran. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Dabigatran recalls in 2026

5 initiated in 2026, 10 in total — newest first
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

Ongoing Impurity / degradation Ascend Laboratories, LLC NDC 0904-7253-04 D-0739-2026
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

Ongoing Impurity / degradation Ascend Laboratories, LLC NDC 0904-7253-68 D-0738-2026
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

Ongoing Impurity / degradation Ascend Laboratories, LLC NDC 0904-7255-68 D-0737-2026
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.

Ongoing Impurity / degradation Ascend Laboratories, LLC NDC 0904-7255-10 D-0736-2026
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.

Ongoing Impurity / degradation Ascend Laboratories, LLC NDC 0904-7254-68 D-0735-2026
Class II · Moderate risk

Dabigatran Etexilate

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Ongoing Nitrosamine impurity Ascend Laboratories, LLC NDC 67877-475-60 D-0130-2025
Class II · Moderate risk

Dabigatran Etexilate

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Ongoing Nitrosamine impurity Ascend Laboratories, LLC NDC 67877-474-60 D-0129-2025
Class II · Moderate risk

Dabigatran Etexilate Capsules

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Ongoing Nitrosamine impurity Ascend Laboratories, LLC NDC 67877-474-60 D-0533-2023
Class II · Moderate risk

Pradaxa (dabigatran etexilate)

Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product

Terminated Failed specification Boehringer Ingelheim Roxane Inc NDC 0597-0149-54 D-067-2013