D-0839-2026 Class II Ongoing
FDA drug recall D-0839-2026 was initiated by Mylan Pharmaceuticals Inc on August 17, 2026 and is designated Class II. Reason for recall: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria The recall status is ongoing. Affected quantity: 47,662 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2026
- Initiation Date
- August 17, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,662 bottles
Product Description
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 Pattern
Nationwide within the U.S
Code Information
Lot #: 3225272, Exp. September 30, 2026