Official recall notice

FDA DrugClass IINotable

FDA Recall: Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceut

Recall date
2026-09-09
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

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

Product description

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

Affected products

Lot #: 3225272, Exp. September 30, 2026

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