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 #: 3225272Exp. September 302026
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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