RecallReported September 9, 2026
Class II recall by Mylan Pharmaceuticals Inc
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institut…
FDA's enforcement report of September 9, 2026 lists a Class II recall by Mylan Pharmaceuticals Inc of Morgantown, WV. Product: Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institut…. Status: Ongoing.
On the record
- Recalling firm
- Mylan Pharmaceuticals Inc
- Location
- Morgantown, WV
- Classification
- Class II
- Status
- Ongoing
- Recall number
- D-0830-2026
- Product type
- Drugs
- Brand names
- MYCOPHENOLATE MOFETIL
- Generic names
- MYCOPHENOLATE MOFETIL
- Recall initiated
- 2026-08-26
- Reported by FDA
- 2026-09-09
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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