Mylan Institutional LLC
Mylan Institutional LLC has 24 FDA recalls (10 Class I), 0 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0291-2025 · Class II · Mar 7, 2025
Newer recall under related name Viatris: Oct 1, 2026, D-0049-2027.
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 24 (10 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Viatris | 26 | 0 | 21 | 1 | Oct 1, 2026 (D-0049-2027) |
| Mylan | 5 | 0 | 0 | 0 | Dec 20, 2016 (D-0444-2017) |
| Meda Pharmaceuticals | 1 | 0 | 10 | 1 | Oct 17, 2011 (D-1418-2012) |
| Mylan Laboratories Limited | 0 | 0 | 33 | 4 | — |
| Dpt Laboratories | 0 | 3 | 24 | 0 | — |
| Viatris Pharmaceuticals | 0 | 0 | 18 | 0 | — |
| Mylan Technologies | 0 | 0 | 7 | 0 | — |
| Mylan Teoranta | 0 | 0 | 7 | 0 | — |
| Mylan Laboratories | 0 | 0 | 1 | 0 | — |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0291-2025 | Class II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10… | Mar 7, 2025 |
| D-0290-2025 | Class II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10… | Mar 7, 2025 |
| D-0132-2025 | Class II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister… | Nov 19, 2024 |
| D-0136-2025 | Class II | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister… | Nov 19, 2024 |
| D-0134-2025 | Class II | Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister… | Nov 19, 2024 |
| D-0135-2025 | Class II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister… | Nov 19, 2024 |
| D-0133-2025 | Class II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister… | Nov 19, 2024 |
| D-0131-2025 | Class II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister… | Nov 19, 2024 |
| D-0601-2021 | Class III | Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose… | May 3, 2021 |
| D-1576-2020 | Class I | Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC… | Aug 17, 2020 |
| D-1575-2020 | Class I | Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC… | Aug 17, 2020 |
| D-1484-2020 | Class I | Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan… | Jul 7, 2020 |
| D-1271-2020 | Class II | Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for… | May 5, 2020 |
| D-1059-2019 | Class I | Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured… | Feb 1, 2019 |
| D-1329-2015 | Class I | Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in… | Apr 23, 2015 |
| D-1333-2015 | Class I | Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only… | Mar 23, 2015 |
| D-1334-2015 | Class I | Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only… | Mar 23, 2015 |
| D-1332-2015 | Class I | Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only… | Mar 23, 2015 |
| D-1328-2015 | Class I | Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials… | Mar 18, 2015 |
| D-1331-2015 | Class I | CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only… | Mar 18, 2015 |