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Carton label Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile Recall 2026

MYCOPHENOLATE MOFETILIssued August 26, 2026Updated Reviewed by the Recall Watch editorial team

MYCOPHENOLATE MOFETIL 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 67457-38 — recalled per FDA on 8/26/2026. Reason: Failed Dissolution Specifications.

Agency
FDA
Issued
Aug 26, 2026
Brand
MYCOPHENOLATE MOFETIL
Distribution
1 states
Lots affected
4
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 August 26, 2026 · Last synced Nov 1, 2026

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.

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Why it was recalled

Failed Dissolution Specifications

Affected products & lot numbers
4 lots called out

Affected Lot Numbers

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

Lot Number
Lot: 3242616
Exp. April 2027
8220216
Exp. Nov 2027
Where was it sold
1 state

U.S. 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 August 26, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot: 3242616, Exp. April 2027, 8220216, Exp. Nov 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.