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.

Recall Number: D-0839-2026

Firm: Mylan Pharmaceuticals Inc

Classification: Class II

Status: Ongoing

Report Date: 20260909

Initiation Date: 20260817

Termination Date:

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

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.