Reported Aug 5, 2026 · Ongoing
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured…
Ascend Laboratories, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ascend Laboratories, LLC · 135 Us Highway 202 206 Ste 15 · Bedminster, NJ · 07921-2608
Is this the product you have?
- Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only
- Manufactured byAlkem Laboratories Ltd., Mumbai, INDIA
- Distributed byMAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04
- Lot codes and dates
- Lot
25141586Exp. April 302027
- Lot
- Amount recalled
- 936 cartons x 12 x 3 x 10 (in blister pack)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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