Ascend Laboratories recalls dabigatran etexilate capsules over failed impurity test results
A 12-month stability test found impurity levels in the dabigatran etexilate capsules, 150 mg and 110 mg, that were outside the allowed limits for Impurity II, Impurity III and total impurities.
What to do
The notice does not give instructions. Read the official notice for details.
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Recall details
- Product
- Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.; Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC…
- Company
- Ascend Laboratories, LLC
- Hazard
- Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
- Units
- 2,717 cartons; 1,753 cartons
- Where sold
- USA Nationwide
- FDA classification
- Class III · Ongoing
- Classified by FDA
- August 4, 2026
- Recall started
- June 30, 2026
- FDA enforcement report
- July 29, 2026
- Identifiers
- Codes: Lot: 25141584, Exp 4/30/2027.
- FDA recall number: D-0736-2026
- Codes: Lot: 25141707, Exp 4/30/2027.
- FDA recall number: D-0735-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10. | Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
- Reason for recall
- Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
- Classification
- Class III (Ongoing)
- Distribution
- USA Nationwide
- Quantity
- 2,717 cartons; 1,753 cartons
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