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
- nitrosamine
- contamination
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.
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · DABIGATRAN ETEXILATE
- HighPrescription drug Dabigatran Etexilate recalled for elevated nitrosamine impurity
FDA (Drugs) · 2024-12-18
- HighDabigatran Etexilate 75 mg capsules recalled for N-nitroso impurity
FDA (Drugs) · 2024-12-18
- HighDabigatran Etexilate Drug Recalled Due to N-nitroso Impurity
FDA (Drugs) · 2023-04-05
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27