Recall: D-0839-2026

Class II - Potentially Harmful

Class IIClassification

2026-08-17Initiated

OngoingStatus

Mylan Pharmaceuticals IncFirm

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

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

Distribution

Nationwide within the U.S

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.