United StatesPrasugrel Tablets, USP 10 mg, Rx only, 30 tablets per bottle (NDC 0378-5186-93), lot 3225272, exp. September 30, 2026, manufactured for Mylan Pharmaceuticals Inc. and made in India, were recalled nationwide in the U.S. The product was recalled because it failed dissolution specifications and did not meet 18-month stability testing acceptance criteria.
What's being recalled
Prasugrel 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 firm: Mylan Pharmaceuticals Inc, Morgantown, WV, United States.
How to identify it
Lot #: 3225272, Exp. September 30, 2026
The hazard
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the U.S
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)