Drug 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
Lots and codes
Lot #: 3225272, Exp. September 30, 2026
Recall details
- Recalling firm
- Mylan Pharmaceuticals Inc, Morgantown, WV
- Quantity
- 47,662 bottles
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 17, 2026
Related products
- Prasugrel – drug information
- NDC 0378-5186 Prasugrel · Prasugrel Hydrochloride 10 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-5185 Prasugrel · Prasugrel Hydrochloride 5 mg/1 · Mylan Pharmaceuticals Inc.