Dabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (150 mg) because testing showed impurities exceeded established limits during stability testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as unlikely to cause adverse health consequences.
Plain-English summary
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister packs packaged in cartons. The recall was initiated after testing showed results outside of specifications for Impurity II, Impurity III, and total impurities during 12-month stability testing.
This recall affects Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister packs further packaged in a carton, Lot 25141583, with an expiration date of April 30, 2027. The affected product was distributed nationwide in the USA.
Consumers should contact their pharmacist or healthcare provider for guidance regarding the use of this medication.
The recalled product
- Product
- DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot: 25141583
- Exp. April 30
- 2027.
UPCs (2)
- 0309047253043
- 0309047255108
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ascend Laboratories, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · DABIGATRAN ETEXILATE
- LowDabigatran Etexilate Capsules Recalled Over Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateDrug Recall: Dabigatran Etexilate Capsules 150 mg by Ascend Laboratories
FDA (Drugs) · 2026-07-29
- ModerateDabigatran Etexilate Capsules Recalled Over Impurity Test Failure
FDA (Drugs) · 2026-07-29
- HighPrescription drug Dabigatran Etexilate recalled for elevated nitrosamine impurity
FDA (Drugs) · 2024-12-18
Same manufacturer · Ascend Laboratories, LLC
See all →- ModerateFDA Recalls Amlodipine and Olmesartan Tablets Over Failed Dissolution Test
FDA (Drugs) · 2026-07-29
- ModerateMinocycline extended-release tablets failed dissolution testing during stability analysis
FDA (Drugs) · 2026-06-17
- HighAscend amlodipine and olmesartan tablets failed dissolution specifications
FDA (Drugs) · 2026-06-10
Same hazard · impurity failure
See all →- ModerateDigoxin Tablets Recalled Due to Failed Impurity and Degradation Specifications
FDA (Drugs) · 2024-04-24
- HighPrescription Rifampin Capsules Recalled Due to Failed Quality Specifications
FDA (Drugs) · 2023-01-25
- SevereOxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
FDA (Drugs) · 2022-03-16
- LowBausch Health Recalls Mephyton Tablets Due to Impurity D Failure
FDA (Drugs) · 2021-02-03
- ModerateAurolife Pharma Recalls Fexofenadine Hydrochloride Tablets for Impurity Failures
FDA (Drugs) · 2019-09-25