Fresh Recalls

Dabigatran Etexilate Capsules: recall status

⚠ Recalls found. Dabigatran Etexilate Capsules is named in 6 official recalls in our current data:

Brand
Ascend Laboratories
Also listed as
Dabigatran etexilate Capsules

Recalls naming this model

FDA Class III · Drug · August 5, 2026

Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC

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

Company / brand: Ascend Laboratories

Affected product: Dabigatran Etexilate Capsules

Official ID D-0737-2026 · Official record ↗

FDA Class III · Drug · August 5, 2026

Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC

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

Company / brand: Ascend Laboratories

Affected product: Dabigatran Etexilate Capsules

Official ID D-0738-2026 · Official record ↗

FDA Class III · Drug · August 5, 2026

Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC

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

Company / brand: Ascend Laboratories

Affected product: Dabigatran Etexilate Capsules

Official ID D-0739-2026 · Official record ↗

FDA Not Yet Classified · Drug · August 5, 2026

Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC

Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impur…

Company / brand: Ascend Laboratories

Affected product: Dabigatran Etexilate Capsules

Official ID EVT-99421-191x326 · Official record ↗

FDA Class III · Drug · July 29, 2026

Dabigatran etexilate Capsules recall — Ascend Laboratories, LLC

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testin…

Company / brand: Ascend Laboratories

Affected product: Dabigatran etexilate Capsules

Official ID D-0735-2026 · Official record ↗

FDA Class III · Drug · July 29, 2026

Dabigatran etexilate Capsules recall — Ascend Laboratories, LLC

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testin…

Company / brand: Ascend Laboratories

Affected product: Dabigatran etexilate Capsules

Official ID D-0736-2026 · Official record ↗

See all Ascend Laboratories recalls →

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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.