FDAHealthJune 30, 2026
Ascend Laboratories, LLC — Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapol
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 30, 2026
USA Nationwide
What's affected?
- Product
- 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.
- Brand
- DABIGATRAN ETEXILATE
- UPC
- 0309047253043
- Lot code
- 25141707
Additional details
Lot: 25141707, Exp 4/30/2027.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 1,753 cartons.
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