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Prasugrel Tablets 10mg
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DRUG RECALLMODERATE

Prasugrel Tablets 10mg

Mylan recalls Prasugrel Tablets 10mg over failed dissolution specs.

What to do

Consumers with the affected product should stop using it and contact Mylan Pharmaceuticals for instructions on return or disposal.

Recalled
Listed
Updated
Agency
FDA
Firm
MYLAN PHARMACEUTICALS INC
Recall ID
99653
Status
ONGOING

Why it was recalled

Mylan Pharmaceuticals is recalling Prasugrel Tablets, USP, 10mg, because the product failed to meet 18-month stability testing acceptance criteria for dissolution specifications.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Prasugrel Tablets, USP

Lot code
3225272, 2026
Strength
10 mg
NDC / UPC
NDC 0378-5186-93

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification