Mycophenolate Mofetil for Injection USP — Class II drug recall D-0734-2026
Ongoing recall by MYLAN PHARMACEUTICALS INC, reported 2026-08-05, distributed nationwide. Presence of precipitate
| Recall number | D-0734-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MYLAN PHARMACEUTICALS INC, Morgantown, WV, United States |
| Recall initiated | 2026-07-02 |
| Classified | 2026-08-04 |
| Reported by FDA | 2026-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 5,688 vials |
| NDC | 67457-0386, 67457-0386-00, 67457-0386-81 |
| Lot numbers | 3241653 |
| Expiration dates | 2027-04-30 |
Product
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & NDC 67457-386-81 (carton label).
Reason for recall
Presence of precipitate
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-0734-2026. 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.