D-0830-2026 Class II Ongoing
FDA drug recall D-0830-2026 was initiated by Mylan Pharmaceuticals Inc on August 26, 2026 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is ongoing. Affected quantity: 11,336 units.
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2026
- Initiation Date
- August 26, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,336 units
Product Description
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.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
U.S. Nationwide
Code Information
Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027