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Prasugrel Tablets recall

Mylan Pharmaceuticals Inc recalled Prasugrel Tablets on September 9, 2026 because of failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria. It was sold nationwide.

Why it was recalled

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

What's 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.

Quantity: 47,662 bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Mylan Pharmaceuticals Inc, Morgantown, WV
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide within the U.S
Status
Ongoing
Recall number
D-0839-2026
Source
U.S. Food and Drug Administration

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