Dabigatran Etexilate 75 mg capsules recalled for N-nitroso impurity
Ascend Laboratories is recalling Dabigatran Etexilate 75 mg capsules nationwide due to manufacturing deviations. Three lots contain N-nitroso-Dabigatran impurity above recommended interim limits.
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: This is an FDA Class II recall involving N-nitroso-Dabigatran, a genotoxic impurity exceeding recommended interim limits in a prescription anticoagulant. While no illnesses or injuries have been reported, the presence of genotoxic impurities in pharmaceuticals represents a recognized risk-of-harm, meeting the rubric criterion for High severity.
Plain-English summary
Ascend Laboratories, LLC is recalling Dabigatran Etexilate 75 mg capsules distributed nationwide in the United States due to manufacturing quality deviations. The recalled product is a prescription anticoagulant used to reduce the risk of blood clots.
The recall affects three lots: 24142328, 24142329, and 24142330, with an expiration date of May 31, 2026. All 1,971 bottles of the affected lot numbers were manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories, LLC.
The issue involves the presence of N-nitroso-Dabigatran impurity in amounts exceeding the FDA's recommended interim limit, representing a current good manufacturing practice (CGMP) deviation.
Consumers who have this medication should contact their pharmacist or healthcare provider. Do not stop taking dabigatran without consulting your healthcare provider, as discontinuing an anticoagulant without medical guidance may have serious health consequences. Healthcare providers and pharmacists should check dispensing records for the affected lot numbers.
The recalled product
- Product
- DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Anticoagulant
- Hazard
- n-nitroso-impurity
- cgmp-deviation
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 (5)
- Lot #: 24142328
- 24142329
- 24142330
- Exp. Date May 31
- 2026.
Distribution
Distributed nationwide across the United States.
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