Prasugrel Tablets — Class II drug recall D-0280-2025
Ongoing recall by MYLAN PHARMACEUTICALS INC, reported 2025-03-26, distributed nationwide. Failed Dissolution Specifications - low dissolution results
| Recall number | D-0280-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MYLAN PHARMACEUTICALS INC, Morgantown, WV, United States |
| Recall initiated | 2025-02-25 |
| Classified | 2025-03-17 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00378-5185, 00378-5185-93, 00378-5186, 00378-5186-93 |
| Lot numbers | 3211073, 3211074, 3211075 |
| Expiration dates | 2026-04-30 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0280-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.