Multi event Drug Recall Enforcement Report Class II voluntary initiated by Mylan Institutional, Inc., originally initiated on 03-07-2025 for the 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. The product was recalled due to super-potent drug: out of specification potency results were obtained.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0291-2025 | 03-07-2025 | 03-26-2025 | Class II | 1,068 cartons | 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. | Super-Potent Drug: Out of specification potency results were obtained. | Ongoing |
| D-0290-2025 | 03-07-2025 | 03-26-2025 | Class II | 347 Cartons | 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, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20. | Super-Potent Drug: Out of specification potency results were obtained. | Ongoing |
Recalled Products
