← Every firm
Mylan Pharmaceuticals Inc FDA Recalls
12 recalls on file across drugs, 3 of them Class I and 6 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, ManufacturedClass IIAug 26, 2026Failed Dissolution Specifications |
| Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., MorgantoClass IIAug 17, 2026Failed Dissolution Specifications; product failed to meet 18 |
| Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., ManufactClass IIJul 24, 2026Failed Dissolution Specifications |
| Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: MClass IIJul 2, 2026Presence of precipitate |
| Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: MyClass IIFeb 24, 2026Failed Dissolution Specifications |
| Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265Class IIFeb 25, 2025Failed Dissolution Specifications - low dissolution results |
| Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packagClass IJul 5, 2022Labeling: Missing label: Label missing from some prefilled |
| Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside Class IApr 12, 2022Labeling: Missing label on the vial |
| Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, MorgaClass IIApr 7, 2022Failed Impurities/Degradation Specifications: High out of sp |
| Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., MorgaClass IIApr 1, 2022Subpotent Drug and Failed Impurities/Degradation Specificati |
| Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx OClass IIJan 21, 2022cGMP deficiencies |
| Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mClass IJan 5, 2022Labeling: Missing Label: label missing from some Semglee pre |