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FDA recall 99421: Ascend Laboratories, LLC: Dabigatran Etexilate Capsules and 2 more

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FDARecall 99421Medicines

What to do

The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.

Read the official notice on accessdata.fda.gov (opens in a new tab)

Hazard

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
Text from FDA, unedited.

FDA classification: Class III. Use is not likely to cause adverse health consequences. Status: Ongoing.

Is it yours? Products and codes

  • 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.

    Lot or code
    Lot: 25141583, Exp. April 30, 2027.
    FDA recall number
    D-0737-2026
    Quantity
    3,600 cartons x 6 x 10 (in blister pack)

  • 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.

    Lot or code
    Lot: 25141585, Exp. April 30, 2027.
    FDA recall number
    D-0738-2026
    Quantity
    924 cartons x 12 x 6 x 10 (in blister pack)

  • 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 or code
    Lot: 25141586, Exp. April 30, 2027.
    FDA recall number
    D-0739-2026
    Quantity
    936 cartons x 12 x 3 x 10 (in blister pack)

Distribution (FDA): USA Nationwide

About this record

Issued by
U.S. Food and Drug Administration
Firm
Ascend Laboratories, LLC
Title
Composed by Recalls Watch from fields of the record; FDA records have no title.

If someone was hurt or swallowed something: call 911, or Poison Help at 1-800-222-1222.

About this recall

What is the hazard?

FDA states: “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”

What should I do if I have this product?

The FDA record of this recall has no instruction for consumers. Compare the lot codes on the notice with your product and follow the notice of the firm. The official report is linked on this page.

How do I know if my product is included?

Compare the lot or code printed on your product with the codes FDA lists on this notice, product by product.

When was this recall published?

FDA published recall 99421 on August 5, 2026.

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