← FDA ENFORCEMENT
D-0734-2026Class II

MYLAN PHARMACEUTICALS INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
MYLAN PHARMACEUTICALS INC
Product type
Drug
Status
Ongoing
Report date
2026-08-05
Distribution
USA Nationwide
Firm state
WV
Product quantity
5688 vials
Initiated by
Voluntary: Firm initiated
Reason for recall

Presence of precipitate

Product description

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).

Code / lot info

Lot #: 3241653, Exp 4/30/2027

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →