Carton label: Mycophenolate Mofetil for injection recall (Mylan Pharmaceuticals Inc)

DrugClass IIOngoing

Summary: Mylan Pharmaceuticals Inc is recalling Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial,. Reason: Failed Dissolution Specifications.

What is being recalled

Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.

Why

Failed Dissolution Specifications

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

U.S. Nationwide

How to tell if yours is affected

Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

More recalls from Mylan Pharmaceuticals Inc · all drug recalls · recalls from August 2026

Official FDA record