Reported Sep 9, 2026 · Ongoing · Updated Sep 16, 2026

Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc.,…

Mylan Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Pharmaceuticals Inc · 3711 Collins Ferry Rd · Morgantown, WV · 26505-2362

Is this the product you have?

  • Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle
  • Manufactured forMylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93
Lot codes and dates
    • Lot #: 3225272
    • Exp. September 30
    • 2026
Amount recalled
47,662 bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 3:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.