FDA Drug recall · Reported August 5, 2026
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.
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
Ascend Laboratories, LLC recalled Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a … - a low-severity action.
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a … was recalled by Ascend Laboratories, LLC in August 5, 2026. Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Im…. Check the official notice for the remedy. Verify recall #D-0739-2026 with the FDA Drug before acting.
The recall
Ascend Laboratories, LLC issued this low-severity FDA Drug recall-Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Im….
- Low
- severity level
- Class III
- classification
- August 5, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0739-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0739-2026) was formally reported on August 5, 2026, with the manufacturer initiating the action on July 16, 2026. It is classified under Low severity (Class III), with a current status of Ongoing. Ascend Laboratories, LLC is listed as the recalling firm, operating out of Bedminster, NJ. Federal records list the affected scope as 936 cartons x 12 x 3 x 10 (in blister pack).
The documented reason for this recall is: 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 Distribution data in the federal record shows the product reached: USA Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,472 drugs & medications recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | D-0739-2026 |
| Date reported | August 5, 2026 |
| Date initiated | July 16, 2026 |
| Recalling firm | Ascend Laboratories, LLC |
| Firm location | Bedminster, NJ |
| Affected scope | 936 cartons x 12 x 3 x 10 (in blister pack) |
| Distribution | USA Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0739-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026