FDAClass IISeptember 9, 2026

Carton label: Mycophenolate Mofetil for injection recall: Failed Dissolution

Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC…

Why was Carton label: Mycophenolate Mofetil for injection recalled?

Failed Dissolution Specifications

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC…
Recalling firm
Mylan Pharmaceuticals Inc
Quantity
11,336 units
Distribution
U.S. Nationwide
Recall date
September 9, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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