Dabigatran Etexilate recall
FDA recall D-0130-2025 · initiated Dec 12, 2024
Ascend Laboratories, LLC recalled Dabigatran Etexilate in Dec 2024 — an FDA Class II recall (D-0130-2025) because CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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: 10,444 bottles
Details
- Product
- Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60
- Recalling company
- Ascend Laboratories, Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Dec 12, 2024
- FDA report date
- Dec 18, 2024
Frequently asked
- Was Dabigatran Etexilate recalled?
- Ascend Laboratories, LLC recalled Dabigatran Etexilate in Dec 2024 — an FDA Class II recall (D-0130-2025) because CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Dabigatran Etexilate recalled?
- Per the FDA enforcement record, the reason for recall D-0130-2025 was: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
- Is a recalled Dabigatran Etexilate 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;. 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-0130-2025.