Mycophenolate Mofetil Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 67457-386
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mycophenolate Mofetil (NDC 67457-386). A significant event, classified as Class II, was initiated on Jul 02, 2026 by Mylan Institutional Llc. The reported reason for this action was: "Presence of precipitate"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of precipitate
Jul 02, 2026
Aug 05, 2026
5688 vials
Recall Profile & Regulatory Data
Event ID
99364
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
MYLAN PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
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).
Batch or Lot Expiration Information
Lot# : 3241653, Exp 4/30/2027
Affected Packages Involved in this Recall
67457-386-00Product
67457-386-81Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
