FDA Drugs recall ·
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial… recall
- Recall number
- D-0830-2026
- Date
- (initiated August 26, 2026)
- Company / brand
- Mylan Pharmaceuticals Inc
3711 Collins Ferry Rd, Morgantown, WV, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11,336 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Dissolution Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
Distribution
U.S. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0830-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.