Prescription Drug Dabigatran Etexilate Recalled for Excess Nitrosamine Impurity
Ascend Laboratories is recalling 12,804 bottles of Dabigatran Etexilate 150mg capsules nationwide due to detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake limit caused by manufacturing process deviations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for N-nitroso-dabigatran (nitrosamine) impurity above the Acceptable Daily Intake limit. No illnesses or injuries have been reported; this represents a precautionary manufacturing quality issue addressing a known carcinogenic impurity.
Plain-English summary
Ascend Laboratories, LLC is recalling 12,804 bottles of Dabigatran Etexilate 150mg capsules distributed nationwide in the United States. The recall was initiated due to detection of N-nitroso-dabigatran (NDAB) impurity levels exceeding the FDA's Acceptable Daily Intake (ADI) limit. The impurity was discovered through manufacturing process deviations detected during quality control testing.
The affected lot numbers are 22142448, 22142449, 22142450 (expiration date 5/2024) and 22143845 (expiration date 7/2024). The product (NDC 67877-475-60) was manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories, LLC of Parsippany, NJ.
Patients with affected medication should verify the lot number on their bottle and contact their healthcare provider with questions about this recall.
The recalled product
- Product
- DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug
- Hazard
- Affected units
- 12,804
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 (6)
- Lot #s: 22142448
- 22142449
- 22142450
- Exp 5/2024
- 22143845
- Exp 7/2024.
UPCs (3)
- 0367877624600
- 0367877474601
- 0367877475608
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same brand · DABIGATRAN ETEXILATE
- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- 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
Same manufacturer · Ascend Laboratories, LLC
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Same hazard · nitrosamine
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