July 2026 FDA Recall Mycophenolate Mofetil by Mylan Pharmaceuticals Inc
D-0734-2026 - Presence of precipitate
This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc on July 2, 2026 for the product Mycophenolate Mofetil. The FDA reported the reason for recall as presence of precipitate. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0734-2026
Presence of precipitate
07-02-2026
08-05-2026
5688 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
