OVERLOOKED

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Class IIIOngoing

Ascend Laboratories, LLC recalls 3 products

Recall date · record updated Aug 5, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Ascend Laboratories, LLC
Reason
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
Hazard
FDA Class III: not likely to cause adverse health consequences (FDA definition).
Who’s affected
USA Nationwide
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99421…

Products (3)

  1. 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.

    Codes/lots: Lot: 25141583, Exp. April 30, 2027.Quantity: 3,600 cartons x 6 x 10 (in blister pack)Recall no. D-0737-2026Class III

  2. 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.

    Codes/lots: Lot: 25141585, Exp. April 30, 2027.Quantity: 924 cartons x 12 x 6 x 10 (in blister pack)Recall no. D-0738-2026Class III

  3. 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.

    Codes/lots: Lot: 25141586, Exp. April 30, 2027.Quantity: 936 cartons x 12 x 3 x 10 (in blister pack)Recall no. D-0739-2026Class III

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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