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Mycophenolate Mofetil

FDA recalls

3 rows

DateCompany and reasonClass
Aug 25, 2026Mylan Pharmaceuticals Inc
Failed Dissolution Specifications
Class II · Ongoing
Jul 1, 2026Mylan Pharmaceuticals Inc
Presence of precipitate
Class II · Ongoing
Apr 29, 2019Par Pharmaceutical, Inc.
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Class I · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).