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
Product description
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
Lot numbers, UPCs & expiration codes
Lot: 25141586, Exp. April 30, 2027.
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0739-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jul 16, 2026
- FDA report date
- Aug 5, 2026
- Quantity
- 936 cartons x 12 x 3 x 10 (in blister pack)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0739-2026, exactly as published.
Show all FDA fields
- City
- Bedminster
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99421
- Address
- 135 Us Highway 202 206 Ste 15
- Code information
- Lot: 25141586, Exp. April 30, 2027.
- Postal code
- 07921-2608
- Report date
- Aug 5, 2026
- Product type
- Drugs
- Recall number
- D-0739-2026
- Classification
- Class III
- Recalling firm
- Ascend Laboratories, LLC
- Product quantity
- 936 cartons x 12 x 3 x 10 (in blister pack)
- Reason for recall
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 16, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 5, 2026