FDA Drugs recall ·
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial… recall
- Recall number
- D-0734-2026
- Date
- (initiated July 2, 2026)
- Company / brand
- Mylan Pharmaceuticals Inc
1311 Pineview Dr, Morgantown, WV, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5688 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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).
Why was it recalled?
Presence of precipitate
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 #: 3241653, Exp 4/30/2027
Distribution
USA 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-0734-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.