Why it was recalled
Failed Dissolution Specifications - low dissolution results
Product description
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
Lot numbers, UPCs & expiration codes
Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
Where it was sold
US Nationwide.
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-0280-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 25, 2025
- FDA report date
- Mar 26, 2025
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MYLAN PHARMACEUTICALS INC
Original FDA data
Every field from FDA enforcement report D-0280-2025, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Ongoing
- Country
- United States
- Event ID
- 96369
- Address
- 1311 Pineview Dr
- Code information
- Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
- Postal code
- 26505-3276
- Report date
- Mar 26, 2025
- Product type
- Drugs
- Recall number
- D-0280-2025
- Classification
- Class II
- Recalling firm
- MYLAN PHARMACEUTICALS INC
- Reason for recall
- Failed Dissolution Specifications - low dissolution results
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Feb 25, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 17, 2025