Reported Jul 29, 2026 · Ongoing
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai,…
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, 150 mg, 20-count carton (2x10), Rx only
- Manufactured byAlkem Laboratories, Mumbai, INDIA
- Distributed byMajor Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10
- Lot codes and dates
- Lot
25141584Exp 4/30/2027
- Lot
- Amount recalled
- 2,717 cartons
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 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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