FDAFDA recall D-0830-2026 · Sep 9, 2026
Mylan Pharmaceuticals Inc: Carton label: Mycophenolate Mofetil for injection recall
Recall found
Product
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
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: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
- Quantity
- 11,336 units
- Distribution
- U.S. Nationwide
- Recalling firm
- Mylan Pharmaceuticals Inc, Morgantown, WV
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-26
Source: openFDA enforcement record D-0830-2026 · search recall number D-0830-2026 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.