FDA Drug recall D-0291-2025
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton,…
- FDA Drug
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton,… by Mylan Institutional, citing super-Potent Drug: Out of specification potency results were obtained.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0291-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-07 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Institutional |
| Distribution | US |
Product
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.
Reason
Super-Potent Drug: Out of specification potency results were obtained.
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 3115773, Exp. 03/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Mylan Institutional
- Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton,…
FDA Drug · Class II · 2025-03-26 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manuf…
FDA Drug · Class II · 2024-12-18 · Mylan Institutional - 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 · 2024-12-18 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
FDA Drug · Class II · 2024-12-18 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
FDA Drug · Class II · 2024-12-18 · Mylan Institutional
All Mylan Institutional recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0291-2025%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.