Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Viatris. FDA records under 10 spellings of its name, each linked to the record. See the Viatris group view.
As of Nov 15, 2026, FDA's public records list Mylan Pharmaceuticals with 82 drug recalls, 68 drug applications, 3 complete response letters and 1 warning letter. The most recent is a drug recall dated Jul 2, 2026: Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per cart….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 2, 2026 | Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LClass II · Presence of precipitate | Drug recalls |
| Feb 24, 2026 | Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Class II · Failed Dissolution Specifications | Drug recalls |
| Feb 25, 2025 | Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-Class II · Failed Dissolution Specifications - low dissolution results | Drug recalls |
| Jan 13, 2023 | Complete response letter, NDA 204311Approved | Complete response letters |
| Aug 6, 2019 | Complete response letter, NDA 204311Approved | Complete response letters |
| Nov 9, 2018 | Warning letter: Cleaning validation, Process validation, StabilityCDER | Warning letters |
| Feb 27, 2015 | Complete response letter, NDA 206610Approved | Complete response letters |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
