Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc. appears in FDA public data with 81 recalls — including 3 Class I (most serious) —, 0 510(k) clearances, 24 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0734-2026, Class II) was initiated on July 2, 2026.
Summary
- Total Recalls
- 81 (3 Class I)
- 510(k) Clearances
- 0
- Inspections
- 24
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0734-2026 | Class II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, | July 2, 2026 |
| D-0399-2026 | Class II | Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, | February 24, 2026 |
| D-0280-2025 | Class II | Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. | February 25, 2025 |
| D-1292-2022 | Class I | Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 4 | July 5, 2022 |
| D-0845-2022 | Class I | Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multip | April 12, 2022 |
| D-0774-2022 | Class II | Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Inst | April 7, 2022 |
| D-0748-2022 | Class II | Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmac | April 1, 2022 |
| D-0452-2022 | Class II | Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aero | January 21, 2022 |
| D-0462-2022 | Class I | Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), | January 5, 2022 |
| D-0049-2021 | Class III | Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bo | October 2, 2020 |
| D-1057-2020 | Class III | Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV | March 23, 2020 |
| D-1031-2020 | Class II | Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morganto | March 9, 2020 |
| D-0791-2020 | Class II | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91. | January 7, 2020 |
| D-0792-2020 | Class II | Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93. | January 7, 2020 |
| D-0186-2020 | Class II | Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals | October 23, 2019 |
| D-0155-2020 | Class II | Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morg | October 18, 2019 |
| D-1848-2019 | Class III | Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals | September 6, 2019 |
| D-0506-2019 | Class III | Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280- | February 13, 2019 |
| D-0424-2019 | Class II | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, | February 1, 2019 |
| D-0428-2019 | Class II | Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500 | January 18, 2019 |