Recall Enforment Report D-0133-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Mylan Institutional, Inc., originally initiated on 11-19-2024 for the product Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 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: 51079-443-20 The product was recalled due to subpotent and superpotent drug. 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-0133-202511-19-202412-18-2024Class II1,664 cartonsLevothyroxine Sodium Tablets, USP, 125 mcg (0.125 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: 51079-443-20Subpotent and Superpotent DrugOngoing
D-0135-202511-19-202412-18-2024Class II690 cartonsLevothyroxine 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: 51079-445-20Subpotent and Superpotent DrugOngoing
D-0132-202511-19-202412-18-2024Class II988 cartonsLevothyroxine Sodium Tablets, USP, 112 mcg (0.112 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: 42292-039-20Subpotent and Superpotent DrugOngoing
D-0134-202511-19-202412-18-2024Class II1,133 cartonsLevothyroxine Sodium Tablets, USP, 137 mcg (0.137 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: 42292-041-20Subpotent and Superpotent DrugOngoing
D-0136-202511-19-202412-18-2024Class II205 cartonsLevothyroxine Sodium Tablets, USP, 175 mcg (0.175 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: 42292-040-20Subpotent and Superpotent DrugOngoing
D-0131-202511-19-202412-18-2024Class II2,835 cartonsLevothyroxine Sodium Tablets, USP, 100 mcg (0.1 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: 51079-442-20Subpotent and Superpotent DrugOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
42292-038Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Institutional Inc.Human Prescription Drug
42292-039Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Institutional Inc.Human Prescription Drug
42292-040Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Institutional Inc.Human Prescription Drug
42292-041Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Institutional Inc.Human Prescription Drug
51079-440Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Institutional Inc.Human Prescription Drug
51079-441Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Institutional Inc.Human Prescription Drug
51079-442Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Institutional Inc.Human Prescription Drug
51079-443Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Institutional Inc.Human Prescription Drug
51079-444Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Institutional Inc.Human Prescription Drug
51079-445Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Institutional Inc.Human Prescription Drug