Reported Sep 9, 2026 · Ongoing · Updated Sep 16, 2026
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only,…
Mylan Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Pharmaceuticals Inc · 3711 Collins Ferry Rd · Morgantown, WV · 26505-2362
Is this the product you have?
- Carton labelMycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only
- Manufactured forMylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81
- Vial LabelMycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only
- Manufactured forMylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00
- Lot codes and dates
- Lot
3242616Exp. April 20278220216Exp. Nov 2027
- Lot
- Amount recalled
- 11,336 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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