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Mycophenolate Mofetil for Injection USP, 500 mg/Vial recall

MYLAN PHARMACEUTICALS INC recalled Mycophenolate Mofetil for Injection USP, 500 mg/Vial on August 5, 2026 because of presence of precipitate. It was sold nationwide.

Why it was recalled

Presence of precipitate

What's 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 India, NDC 67457-386-00 (vial label) & NDC 67457-386-81 (carton label).

Quantity: 5688 vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
MYLAN PHARMACEUTICALS INC, Morgantown, WV
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
USA Nationwide
Status
Ongoing
Recall number
D-0734-2026
Source
U.S. Food and Drug Administration

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