MYLAN PHARMACEUTICALS INC Mycophenolate Mofetil for Injection Recall
Announced 2026-08-05 · FDA
The FDA is recalling 5,688 vials of Mycophenolate Mofetil for Injection USP, 500 mg per vial, 4 vials per carton, Rx only, distributed nationwide in the United States. The recall is due to the presence of precipitate in the product. This recall covers Lot 3241653 with expiration 04/30/2027.
| Brand | MYLAN PHARMACEUTICALS INC |
|---|---|
| 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 | Presence of precipitate |
| Severity | moderate |
| Units affected | 5688 |
| Distribution | USA Nationwide |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any vials from Lot 3241653.
- If you have a product from this lot, stop use and contact your healthcare provider for guidance.
- Return the recalled vials to the place of purchase or to the facility that dispensed them for disposition or replacement per their instructions.
- For more information, contact Mylan Institutional LLC or the FDA recall notice.
How to identify the recalled item
| Lot / date codes | Lot #: 3241653, Exp 4/30/2027 |
|---|---|
| Lot / date codes | Lot #: 3241653, Exp 4/30/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other MYLAN PHARMACEUTICALS INC recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.