CLASS II ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
Carton label: Mycophenolate Mofetil for injection recalled
Mylan Pharmaceuticals is recalling Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile Dose Vials, distributed nationwide in the US. The recall was initiated on 26 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0830-2026
- FDA event ID
- 99750
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Manufacturer
- Mylan Institutional LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Aug 2026
- FDA classified
- 3 Sep 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Aug 2026 | Recall initiated by company | |
| 3 Sep 2026 | Classified by FDA | +8 days |
| 9 Sep 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Prasugrel Tablets, USP, 5 mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Mycophenolate Mofetil recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate Mofetil | Par Pharmaceutical | Particulate Matter | Nationwide |
| Drug | CLASS III | Mycophenolate Mofetil, Bulk Powder, Quantity recalled | Attix Pharmaceuticals | Manufacturing (CGMP) Deviations | CO |
| Drug | CLASS II | Mycophenolate Mofetil, Capsule, 250 mg recalled by Aidapak Services | Aidapak Services | Packaging Defects | 4 states |
| Drug | CLASS II | Mycophenolate Mofetil, Capsule, 250 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |