D-0734-2026 Class II Ongoing

Recalled by MYLAN PHARMACEUTICALS INC — Morgantown, WV

FDA drug recall D-0734-2026 was initiated by MYLAN PHARMACEUTICALS INC on Jul 2, 2026 and is designated Class II. Reason for recall: Presence of precipitate The recall status is ongoing. Affected quantity: 5688 vials.

Recall details

Product Type
Drugs
Report Date
Aug 5, 2026
Initiation Date
Jul 2, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5688 vials

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).

Reason for recall

Presence of precipitate

Distribution pattern

USA Nationwide

Code information

Lot #: 3241653, Exp 4/30/2027

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0734-2026
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0734-2026. Report a data issue: hello@regdatalab.com.