Elevated site urgencyFDA Class II

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 I

Presence of precipitate

Agency
FDA Drug
Recall date
Jul 2, 2026
Status
Ongoing
Company
MYLAN PHARMACEUTICALS INC

1. What product was recalled?

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 I

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.

Quantity: 5688 vials

Code or lot text: Lot #: 3241653, Exp 4/30/2027

LOT
Exp 4/30/2027
LOT
Lot #: 3241653
NDC
67457-386
NDC
67457-386-00
NDC
67457-386-81
RECALL-NUMBER
D-0734-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

Presence of precipitate

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. unchanged
  2. created

10. Where is the official source?

Open the official FDA Drug source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.