FDA Drug recall D-0839-2026
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made… by Mylan Pharmaceuticals, citing failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0839-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-17 |
| Published | 2026-09-09 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
Reason
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Identifiers
| ndc | 0378-5185-93 |
|---|---|
| ndc | 0378-5186-93 |
| code_info | Lot #: 3225272, Exp. September 30, 2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-23 05:30 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-03-11 · Mylan Pharmaceuticals - 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 · 2025-03-26 · Mylan Pharmaceuticals
All Mylan Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0839-2026%22
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