FDA recall D-0839-2026

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

Distribution

Nationwide within the U.S

Key facts

Status

Ongoing

Initiation date

2026-08-17

Report date

2026-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0839-2026