FDAFDA recall D-0734-2026 · Aug 5, 2026
MYLAN PHARMACEUTICALS INC: Mycophenolate Mofetil for Injection USP recall
Recall found
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).
Reason for recall
Presence of precipitate
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: 3241653, Exp 4/30/2027
- Quantity
- 5688 vials
- Distribution
- USA Nationwide
- Recalling firm
- MYLAN PHARMACEUTICALS INC, Morgantown, WV
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-02
Source: openFDA enforcement record D-0734-2026 · search recall number D-0734-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.