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FDA recall 99364: MYLAN PHARMACEUTICALS INC: Mycophenolate Mofetil for Injection USP

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FDARecall 99364Medicines

What to do

The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.

Read the official notice on accessdata.fda.gov (opens in a new tab)

Hazard

Why it was recalled

Presence of precipitate
Text from FDA, unedited.

FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.

Is it yours? Products and codes

  • 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).

    Lot or code
    Lot #: 3241653, Exp 4/30/2027
    FDA recall number
    D-0734-2026
    Quantity
    5688 vials

Distribution (FDA): USA Nationwide

About this record

Issued by
U.S. Food and Drug Administration
Firm
MYLAN PHARMACEUTICALS INC (other notices of this firm)
Title
Composed by Recalls Watch from fields of the record; FDA records have no title.

If someone was hurt or swallowed something: call 911, or Poison Help at 1-800-222-1222.

About this recall

What is the hazard?

FDA states: “Presence of precipitate”

What should I do if I have this product?

The FDA record of this recall has no instruction for consumers. Compare the lot codes on the notice with your product and follow the notice of the firm. The official report is linked on this page.

How do I know if my product is included?

Compare the lot or code printed on your product with the codes FDA lists on this notice, product by product.

When was this recall published?

FDA published recall 99364 on August 5, 2026.

Other notices of MYLAN PHARMACEUTICALS INC

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