Mylan Pharmaceuticals Inc recalls Carton label: Mycophenolate Mofetil for injection
- Recalling company
- Mylan Pharmaceuticals Inc
- 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
- Failed Dissolution Specifications
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 26, 2026
- Reported
- Sep 9, 2026
- Distribution
- U.S. Nationwide
- Status
- Ongoing
- Quantity
- 11,336 units
- Lot / codes
- Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
- Company location
- Morgantown, WV
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0830-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0830-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.