Dabigatran Etexilate Capsule, Coated Pellets
FDA Recall NDC 0904-7254
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Dabigatran Etexilate (NDC 0904-7254). A significant event, classified as Class III, was initiated on Jul 16, 2026 by Major Pharmaceuticals. The reported reason for this action was: "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 recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
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
Jul 16, 2026
Aug 05, 2026
3,600 cartons x 6 x 10 (in blister pack)
Recall Profile & Regulatory Data
Event ID
99421
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
Batch or Lot Expiration Information
Lot# Lot: 25141583, Exp. April 30, 2027.
Affected Packages Involved in this Recall
0904-7253-35Product
0904-7253-04Product
0904-7253-68Product
0904-7254-35Product
0904-7254-68Product
0904-7255-35Product
0904-7255-10Product
0904-7255-68Product
Class III Ongoing
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
Jul 16, 2026
Aug 05, 2026
924 cartons x 12 x 6 x 10 (in blister pack)
Recall Profile & Regulatory Data
Event ID
99421
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
Batch or Lot Expiration Information
Lot# Lot: 25141585, Exp. April 30, 2027.
Affected Packages Involved in this Recall
0904-7253-35Product
0904-7253-04Product
0904-7253-68Product
0904-7254-35Product
0904-7254-68Product
0904-7255-35Product
0904-7255-10Product
0904-7255-68Product
Class III Ongoing
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
Jul 16, 2026
Aug 05, 2026
936 cartons x 12 x 3 x 10 (in blister pack)
Recall Profile & Regulatory Data
Event ID
99421
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
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.
Batch or Lot Expiration Information
Lot# Lot: 25141586, Exp. April 30, 2027.
Affected Packages Involved in this Recall
0904-7253-35Product
0904-7253-04Product
0904-7253-68Product
0904-7254-35Product
0904-7254-68Product
0904-7255-35Product
0904-7255-10Product
0904-7255-68Product
Class III Ongoing
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.
Jun 30, 2026
Jul 29, 2026
1,753 cartons
Recall Profile & Regulatory Data
Event ID
99330
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot: 25141707, Exp 4/30/2027.
Affected Packages Involved in this Recall
0904-7253-35Product
0904-7253-04Product
0904-7253-68Product
0904-7254-35Product
0904-7254-68Product
0904-7255-35Product
0904-7255-10Product
0904-7255-68Product
Class III Ongoing
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.
Jun 30, 2026
Jul 29, 2026
2,717 cartons
Recall Profile & Regulatory Data
Event ID
99330
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot: 25141584, Exp 4/30/2027.
Affected Packages Involved in this Recall
0904-7253-35Product
0904-7253-04Product
0904-7253-68Product
0904-7254-35Product
0904-7254-68Product
0904-7255-35Product
0904-7255-10Product
0904-7255-68Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
