OVERLOOKED

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Class IIIOngoing

Ascend Laboratories, LLC recalls 2 products

Recall date · record updated Jul 29, 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 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.
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=99330…

Products (2)

  1. 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.

    Codes/lots: Lot: 25141707, Exp 4/30/2027.Quantity: 1,753 cartonsRecall no. D-0735-2026Class III

  2. 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.

    Codes/lots: Lot: 25141584, Exp 4/30/2027.Quantity: 2,717 cartonsRecall no. D-0736-2026Class 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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