Carton label recall
Mylan Pharmaceuticals Inc recalled Carton label on September 9, 2026 because of failed dissolution specifications. It was sold nationwide.
Why it was recalled
Failed Dissolution Specifications
What's recalled
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.
Quantity: 11,336 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Mylan Pharmaceuticals Inc, Morgantown, WV
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
U.S. Nationwide - Status
- Ongoing
- Recall number
- D-0830-2026
- Source
- U.S. Food and Drug Administration
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