Why it was recalled
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
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.
Lot numbers, UPCs & expiration codes
Lot #: 3225272, Exp. September 30, 2026
Where it was sold
Nationwide within the U.S
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0839-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 17, 2026
- FDA report date
- Sep 9, 2026
- Quantity
- 47,662 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0839-2026, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Ongoing
- Country
- United States
- Event ID
- 99653
- Address
- 3711 Collins Ferry Rd
- Code information
- Lot #: 3225272, Exp. September 30, 2026
- Postal code
- 26505-2362
- Report date
- Sep 9, 2026
- Product type
- Drugs
- Recall number
- D-0839-2026
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc
- Product quantity
- 47,662 bottles
- Reason for recall
- Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the U.S
- Recall initiation date
- Aug 17, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 11, 2026