FDA Drug recall D-0135-2025
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
- FDA Drug
- Class II
- ongoing
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man… by Mylan Institutional, citing subpotent and Superpotent Drug.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0135-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-19 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Institutional |
| Distribution | US |
Product
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-445-20
Reason
Subpotent and Superpotent Drug
Identifiers
| ndc | 51079-440-01 |
|---|---|
| ndc | 51079-440-20 |
| ndc | 51079-444-01 |
| ndc | 51079-444-20 |
| ndc | 51079-441-01 |
| ndc | 51079-441-20 |
| ndc | 51079-442-01 |
| ndc | 51079-442-20 |
| ndc | 51079-443-01 |
| ndc | 51079-443-20 |
| ndc | 51079-445-01 |
| ndc | 51079-445-20 |
| code_info | Lot #: 3115924, Exp. Date 06/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0135-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.