Mycophenolate Mofetil for Injection USP recall
FDA recall D-0734-2026 · initiated Jul 2, 2026
MYLAN PHARMACEUTICALS INC recalled Mycophenolate Mofetil for Injection USP in Jul 2026 — an FDA Class II recall (D-0734-2026) because Presence of precipitate.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of precipitate
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5688 vials
Details
- 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.
- Recalling company
- Mylan Gmbh
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jul 2, 2026
- FDA report date
- Aug 5, 2026
Frequently asked
- Was Mycophenolate Mofetil for Injection USP recalled?
- MYLAN PHARMACEUTICALS INC recalled Mycophenolate Mofetil for Injection USP in Jul 2026 — an FDA Class II recall (D-0734-2026) because Presence of precipitate. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Mycophenolate Mofetil for Injection USP recalled?
- Per the FDA enforcement record, the reason for recall D-0734-2026 was: Presence of precipitate
- Is a recalled Mycophenolate Mofetil for Injection USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Mycophenolate Mofetil for Injection USP are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: 3241653, Exp 4/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0734-2026.