Dabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (75 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 has classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences.
Plain-English summary
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10) blister packs packaged in cartons. This recall affects lot 25141585 with an expiration date of April 30, 2027.
The recall was initiated after testing showed results outside of specifications (OOS) for Impurity II, Impurity III, and Total impurities during 12-month stability testing.
This recall is being conducted nationwide in the USA. Patients should contact their healthcare provider or pharmacist 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: 25141585
- 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
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- ModerateDrug Recall: Dabigatran Etexilate Capsules 150 mg by Ascend Laboratories
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- ModerateDabigatran Etexilate Capsules Recalled Over Impurity Test Failure
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- HighPrescription drug Dabigatran Etexilate recalled for elevated nitrosamine impurity
FDA (Drugs) · 2024-12-18
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