FDA Drug recall D-0280-2025
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378…
- FDA Drug
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378… by Mylan Pharmaceuticals, citing failed Dissolution Specifications - low dissolution results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0280-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-25 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
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
Failed Dissolution Specifications - low dissolution results
Identifiers
| ndc | 0378-5185-93 |
|---|---|
| ndc | 0378-5186-93 |
| code_info | Lot # 3211073, 3211074, 3211075, Exp 4/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0280-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.