Recall D-0839-2026

US Class II Ongoing · initiated 2026-08-17

Recalling firm

Mylan Pharmaceuticals Inc, WV

Product

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.

Reason for recall

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

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