FDA Recall D-0280-2025
MYLAN PHARMACEUTICALS INC · Morgantown, WV
Class II Ongoing 443 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Reason for recall
Failed Dissolution Specifications - low dissolution results
Recall record
- Recall number
D-0280-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide.
- Recall initiated
- 2025-02-25
- Classified by FDA Center
- 2025-03-17
- FDA published
- 2025-03-26
- Recalling firm
- MYLAN PHARMACEUTICALS INC
- Firm location
- Morgantown, WV
Drug identification
- Brand name(s)
- PRASUGREL
- Generic name(s)
- PRASUGREL
- Manufacturer(s)
- Mylan Pharmaceuticals Inc.
- NDC(s)
0378-5185, 0378-5186- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.