August 2026 FDA Recall Mycophenolate Mofetil by Mylan Pharmaceuticals Inc
D-0830-2026 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc on August 26, 2026 for the product Mycophenolate Mofetil. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0830-2026

Reason for Recall
Failed Dissolution Specifications
Initiated
08-26-2026
Reported
09-09-2026
Quantity
11,336 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99750
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

67457-386-00 Mycophenolate Mofetil
67457-386-81 Mycophenolate Mofetil