Carton label: Mycophenolate Mofetil for injection recall
FDA recall D-0830-2026 · initiated Aug 26, 2026
Mylan Pharmaceuticals Inc recalled Carton label: Mycophenolate Mofetil for injection in Aug 2026 — an FDA Class II recall (D-0830-2026) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 11,336 units
Details
- 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.
- Recalling company
- Mylan Pharmaceuticals Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Aug 26, 2026
- FDA report date
- Sep 9, 2026
Frequently asked
- Was Carton label: Mycophenolate Mofetil for injection recalled?
- Mylan Pharmaceuticals Inc recalled Carton label: Mycophenolate Mofetil for injection in Aug 2026 — an FDA Class II recall (D-0830-2026) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Carton label: Mycophenolate Mofetil for injection recalled?
- Per the FDA enforcement record, the reason for recall D-0830-2026 was: Failed Dissolution Specifications
- Is a recalled Carton label: Mycophenolate Mofetil for injection 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 Carton label: Mycophenolate Mofetil for injection are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 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-0830-2026.