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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.

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

Class II Medicine & devices FDA September 9, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Mylan Pharmaceuticals Inc — Morgantown, WV
Severity
Class II — moderate
Reported
September 9, 2026
Quantity
47,662 bottles
Recall number
D-0839-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide within the U.S

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