Class IIDrugOngoing

Mylan Pharmaceuticals Inc

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

Details

Recall number: D-0839-2026
Event ID: 99653
Recall initiated: Aug 17, 2026
Classified: Sep 11, 2026
Reported: Sep 9, 2026
Quantity: 47,662 bottles
Distribution: Nationwide within the U.S
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Morgantown, WV, United States
Lot / code info: Lot #: 3225272, Exp. September 30, 2026