Dabigatran Etexilate Drug Recalled Due to N-nitroso Impurity
Ascend Laboratories is recalling 13,560 bottles of Dabigatran Etexilate 75 mg capsules nationwide because testing detected N-nitroso-dabigatran impurity levels above acceptable limits. The issue stems from a manufacturing quality control deviation.
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 with no reported illnesses or injuries. The hazard is a manufacturing-related impurity (N-nitroso-dabigatran) at levels exceeding established acceptable daily intake limits in a prescription medication, representing a risk-of-harm situation without yet-reported adverse health events.
Plain-English summary
Ascend Laboratories, LLC is recalling 13,560 bottles of Dabigatran Etexilate Capsules, 75 mg nationwide in the United States. The affected lots are 22142462, 22142463, 22142464 (with expiration date 5/2024) and 22143000, 22143001, 22143002 (with expiration date 6/2024).
The recall results from a Current Good Manufacturing Practice (CGMP) deviation. Testing identified N-nitroso-dabigatran (NDAB) impurity levels in the affected lots that exceed the Acceptable Daily Intake Limit established for this substance.
Ascend Laboratories, LLC distributed the product (NDC 67877-474-60), which was manufactured by Alkem Laboratories Ltd. in India. The product was distributed nationwide.
Persons who have received the affected product should contact their healthcare provider or pharmacist for guidance regarding their medication therapy. The medication should not be discarded without consulting a healthcare professional about proper disposal methods.
The recalled product
- Product
- DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug
- Affected units
- 13,560
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 (8)
- Lot #s: 22142462
- 22142463
- 22142464
- Exp 5/2024
- 22143000
- 22143001
- 22143002
- Exp 6/2024.
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
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