CLASS II ONGOING Drug recall · Reported 5 Aug 2026 · FDA Enforcement Report
Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalled
Mylan Pharmaceuticals is recalling Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per, distributed nationwide in the US. The recall was initiated on 2 Jul 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-0734-2026
- FDA event ID
- 99364
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Manufacturer
- Mylan Institutional LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jul 2026
- FDA classified
- 4 Aug 2026
- Reported
- 5 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Jul 2026 | Recall initiated by company | |
| 4 Aug 2026 | Classified by FDA | +33 days |
| 5 Aug 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of precipitate
Product as listed by the FDA
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).
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Presence of precipitate
Which lots are affected?
Lot #: 3241653, Exp 4/30/2027
Where was it sold?
USA 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 | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | 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 | 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 | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | 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 |