Class II

Drug Recall: 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.

Mylan Pharmaceuticals Inc · August 17, 2026

Reason for Recall

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

Distribution

Nationwide within the U.S

States Affected

NATIONWIDE

Quantity Affected

47,662 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0839-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Mylan Pharmaceuticals Inc Drug Recall: 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. | SafeCheck