Reported Aug 5, 2026 · Ongoing

Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for:…

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 · 1311 Pineview Dr · Morgantown, WV · 26505-3276

Is this the product you have?

  • Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only
  • Manufactured forMylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & NDC 67457-386-81 (carton label)
Lot codes and dates
    • Lot #: 3241653
    • Exp 4/30/2027
Amount recalled
5688 vials

Where it was sold

  • Nationwide

Why it was recalled

Presence of precipitate

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 3:29 PM UTC

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