Mylan Pharmaceuticals Inc.

FDA Regulatory Profile

Summary

Total Recalls
80 (3 Class I)
510(k) Clearances
0
Inspections
23
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0399-2026Class IIIsotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, ManufacturedFebruary 24, 2026
D-0280-2025Class IIPrasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc.February 25, 2025
D-1292-2022Class IInsulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 4July 5, 2022
D-0845-2022Class IInsulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL MultipApril 12, 2022
D-0774-2022Class IIRifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan InstApril 7, 2022
D-0748-2022Class IITravoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan PharmacApril 1, 2022
D-0452-2022Class IIProctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aeroJanuary 21, 2022
D-0462-2022Class ISemglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), January 5, 2022
D-0049-2021Class IIICandesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count boOctober 2, 2020
D-1057-2020Class IIITacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV March 23, 2020
D-1031-2020Class IISotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. MorgantoMarch 9, 2020
D-0791-2020Class IINizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.January 7, 2020
D-0792-2020Class IINizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.January 7, 2020
D-0186-2020Class IIAlprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals October 23, 2019
D-0155-2020Class IIPrasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorgOctober 18, 2019
D-1848-2019Class IIIGatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals September 6, 2019
D-0506-2019Class IIIDiltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-February 13, 2019
D-0424-2019Class IIDymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray,February 1, 2019
D-0428-2019Class IIFexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500January 18, 2019
F-0859-2019Class IIDrNatura Toxinout Kit Broad Spectrum Detoxification ProgramDecember 10, 2018