Mylan Pharmaceuticals recalls

12 official recalls and safety alerts involving Mylan Pharmaceuticals since 2022-01, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Mylan Pharmaceuticals or the relevant agency.

1. 2026-09-09
2. US
   Drugs & medicalClass II

   Mylan Pharmaceuticals Inc recalls Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505,…

   Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

   FDA · DrugMylan Pharmaceuticals IncNationwide within the U.SOfficial notice →
3. US
   Drugs & medicalClass II

   Mylan Pharmaceuticals Inc recalls Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan…

   Failed Dissolution Specifications

   FDA · DrugMylan Pharmaceuticals IncU.S. NationwideOfficial notice →
4. 2026-08-26
5. US
   Drugs & medicalClass II

   Mylan Pharmaceuticals Inc recalls Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan…

   Failed Dissolution Specifications

   FDA · DrugMylan Pharmaceuticals IncUS Nationwide.Official notice →
6. 2026-08-05
7. US
   Drugs & medicalClass II

   MYLAN PHARMACEUTICALS INC recalls Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan…

   Presence of precipitate

   FDA · DrugMYLAN PHARMACEUTICALS INCUSA NationwideOfficial notice →
8. 2026-03-11
9. US
   Drugs & medicalClass II

   MYLAN PHARMACEUTICALS INC recalls Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan…

   Failed Dissolution Specifications

   FDA · DrugMYLAN PHARMACEUTICALS INCNationwide within the United StatesOfficial notice →
10. 2025-03-26
11. US
    Drugs & medicalClass II

    MYLAN PHARMACEUTICALS INC recalls Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC…

    Failed Dissolution Specifications - low dissolution results

    FDA · DrugMYLAN PHARMACEUTICALS INCUS Nationwide.Official notice →
12. 2022-08-03
13. US
    Drugs & medicalClass I

    Mylan Pharmaceuticals Inc recalls Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons…

    Labeling: Missing label: Label missing from some prefilled pens.

    FDA · DrugMylan Pharmaceuticals IncProduct was distributed nationwide within the United StatesOfficial notice →
14. 2022-05-04
15. US
    Drugs & medicalClass I

    Mylan Pharmaceuticals Inc recalls Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx…

    Labeling: Missing label on the vial

    FDA · DrugMylan Pharmaceuticals IncUSA nationwide.Official notice →
16. 2022-04-27
17. US
    Drugs & medicalClass II

    Mylan Pharmaceuticals Inc recalls Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505…

    Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.

    FDA · DrugMylan Pharmaceuticals IncNationwide in the USAOfficial notice →
18. 2022-04-13
19. US
    Drugs & medicalClass II

    Mylan Pharmaceuticals Inc recalls Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV…

    Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine…

    FDA · DrugMylan Pharmaceuticals IncNationwide in the USA and Puerto RicoOfficial notice →
20. 2022-02-02
21. US
    Drugs & medicalClass II

    Mylan Pharmaceuticals Inc recalls Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only,…

    cGMP deficiencies

    FDA · DrugMylan Pharmaceuticals IncRecalled product was distributed nationwide within the United States.Official notice →
22. 2022-01-26
23. US
    Drugs & medicalClass I

    Mylan Pharmaceuticals Inc recalls Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled…

    Labeling: Missing Label: label missing from some Semglee prefilled pens.

    FDA · DrugMylan Pharmaceuticals IncNationwide in the USA and Thailand.Official notice →