Drug Recall: Dabigatran Etexilate Capsules 150 mg by Ascend Laboratories
Ascend Laboratories is recalling 2,717 cartons of Dabigatran Etexilate Capsules, 150 mg, because stability testing found impurities above specification.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries; the issue is a quality specification failure unlikely to cause adverse health consequences, fitting Moderate rather than Low because it is not cosmetic or packaging-only.
Plain-English summary
Ascend Laboratories, LLC is recalling 2,717 cartons of Dabigatran Etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only. The affected lot is 25141584, with expiration 4/30/2027. The product was distributed nationwide in the USA and has NDC 0904-7255-10.
The recall was initiated because an out-of-specification (OOS) result was observed during related substance testing for 12-month long-term stability. The test failed specifications for Impurity II, Impurity III, and total impurities.
Consumers who have this specific lot may be affected. The FDA classifies this as a Class III recall, meaning use of the product is unlikely to cause adverse health consequences. The recall notice does not include specific consumer instructions; patients should consult their healthcare provider or pharmacist with questions.
The recalled product
- Product
- DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Oral Prescription Drug
- Hazard
- drug-impurity
- degradation-specification-failure
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 (2)
- Lot: 25141584
- Exp 4/30/2027.
UPCs (2)
- 0309047253043
- 0309047255108
Distribution
Distributed nationwide across the United States.
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