Mylan Pharmaceuticals Inc: Prasugrel Tablets, Usp, 10mg

Prasugrel Tablets Recall Summary Mylan Pharmaceuticals is recalling 10mg Prasugrel Tablets (NDC 0378-5186-93) distributed nationwide because the medication failed to dissolve properly during stability testing and did not meet quality standards after 18 months of storage. This recall affects prescription bottles containing 30 tablets that were manufactured in India and distributed across all U.S. states and Washington D.C. Prasugrel is a blood clot-preventing medication used by patients with heart conditions.

Recalling firm

Mylan Pharmaceuticals Inc

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

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-08-17

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide within the U.S

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/9e7af78e-fae7-4ab2-806c-62940f44113c