Recalls / Class II
Class IID-0280-2025
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
- Brand name
- Prasugrel
- Generic name
- Prasugrel
- Active ingredient
- Prasugrel Hydrochloride
- Route
- Oral
- NDCs
- 0378-5185, 0378-5186
- FDA application
- ANDA205927
- Affected lot / code info
- Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
Why it was recalled
Failed Dissolution Specifications - low dissolution results
Recalling firm
- Firm
- MYLAN PHARMACEUTICALS INC
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1311 Pineview Dr, N/A, Morgantown, West Virginia 26505-3276
Distribution
- Quantity
- N/A
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-02-25
- FDA classified
- 2025-03-17
- Posted by FDA
- 2025-03-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0280-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.