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Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial Recall 2026

MYCOPHENOLATE MOFETILIssued July 2, 2026Updated Reviewed by the Recall Watch editorial team

MYCOPHENOLATE MOFETIL 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- — recalled per FDA on 7/2/2026. Reason: Presence of precipitate.

Agency
FDA
Issued
Jul 2, 2026
Brand
MYCOPHENOLATE MOFETIL
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued July 2, 2026 · Last synced Nov 1, 2026

What's recalled

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).

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Why it was recalled

Presence of precipitate

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot #: 3241653
Exp 4/30/2027
Where was it sold
1 state

USA Nationwide

nationwide
Official noticefda.gov
More recalls like this
5 related — by brand, contaminant, and category

Frequently asked questions

Is the MYCOPHENOLATE MOFETIL recall still active?

Yes, this recall is currently active as of July 2, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #: 3241653, Exp 4/30/2027. Check the label on your product.

What should I do if I have the recalled MYCOPHENOLATE MOFETIL?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.