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Class II · ModerateActive recall

Prasugrel

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 3225272, Exp. September 30, 2026
Where it was soldNationwide within the U.S
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand namePRASUGREL
Generic namePRASUGREL
Active ingredient(s)PRASUGREL HYDROCHLORIDE
Distributed by / forMylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India
NDC0378-5186-93
Show the full FDA record
Full product labelPrasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
Recalling firmMylan Pharmaceuticals Inc
DistributionNationwide within the U.S
Quantity47,662 bottles
Recall initiated2026-08-17
Report date2026-09-09
Recall completed—
Recall numberD-0839-2026
ClassificationClass II
FDA statusOngoing
Origin on fileMorgantown WV United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.