Dabigatran etexilate Capsules recall
FDA recall D-0735-2026 · initiated Jun 30, 2026
Ascend Laboratories, LLC recalled Dabigatran etexilate Capsules in Jun 2026 — an FDA Class III recall (D-0735-2026) because 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.
Unlikely to cause harm but violates FDA labeling or manufacturing 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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,753 cartons
Details
- Product
- 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.
- Recalling company
- Ascend Laboratories, Ltd
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jun 30, 2026
- FDA report date
- Jul 29, 2026
Frequently asked
- Was Dabigatran etexilate Capsules recalled?
- Ascend Laboratories, LLC recalled Dabigatran etexilate Capsules in Jun 2026 — an FDA Class III recall (D-0735-2026) because 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Dabigatran etexilate Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0735-2026 was: 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.
- Is a recalled Dabigatran etexilate Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Dabigatran etexilate Capsules are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot: 25141707, Exp 4/30/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0735-2026.