Levothyroxine Sodium Tablet
FDA Recall NDC 51079-445
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Levothyroxine Sodium (NDC 51079-445). A significant event, classified as Class II, was initiated on Mar 07, 2025 by Mylan Institutional Inc.. The reported reason for this action was: "Super-Potent Drug: Out of specification potency results were obtained."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Super-Potent Drug: Out of specification potency results were obtained.
Mar 07, 2025
Mar 26, 2025
1,068 cartons
Recall Profile & Regulatory Data
Event ID
96428
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Institutional, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot 3115773, Exp. 03/31/2025
Affected Packages Involved in this Recall
51079-440-01Product
51079-440-20Product
51079-444-01Product
51079-444-20Product
51079-441-01Product
51079-441-20Product
51079-442-01Product
51079-442-20Product
51079-443-01Product
51079-443-20Product
51079-445-01Product
51079-445-20Product
Class II Ongoing
Super-Potent Drug: Out of specification potency results were obtained.
Mar 07, 2025
Mar 26, 2025
347 Cartons
Recall Profile & Regulatory Data
Event ID
96428
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Institutional, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot 3116074, Exp. 09/30/2025
Affected Packages Involved in this Recall
51079-440-01Product
51079-440-20Product
51079-444-01Product
51079-444-20Product
51079-441-01Product
51079-441-20Product
51079-442-01Product
51079-442-20Product
51079-443-01Product
51079-443-20Product
51079-445-01Product
51079-445-20Product
Class II Ongoing
Subpotent and Superpotent Drug
Nov 19, 2024
Dec 18, 2024
2,835 cartons
Recall Profile & Regulatory Data
Event ID
95817
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Institutional, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Levothyroxine 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: 51079-442-20
Batch or Lot Expiration Information
Lot# : 3115936, Exp. Date 07/2025
Affected Packages Involved in this Recall
51079-440-01Product
51079-440-20Product
51079-444-01Product
51079-444-20Product
51079-441-01Product
51079-441-20Product
51079-442-01Product
51079-442-20Product
51079-443-01Product
51079-443-20Product
51079-445-01Product
51079-445-20Product
Class II Ongoing
Subpotent and Superpotent Drug
Nov 19, 2024
Dec 18, 2024
1,664 cartons
Recall Profile & Regulatory Data
Event ID
95817
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Institutional, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
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
Batch or Lot Expiration Information
Lot# : 3115893, Exp. Date 6/2025
Affected Packages Involved in this Recall
51079-440-01Product
51079-440-20Product
51079-444-01Product
51079-444-20Product
51079-441-01Product
51079-441-20Product
51079-442-01Product
51079-442-20Product
51079-443-01Product
51079-443-20Product
51079-445-01Product
51079-445-20Product
Class II Ongoing
Subpotent and Superpotent Drug
Nov 19, 2024
Dec 18, 2024
690 cartons
Recall Profile & Regulatory Data
Event ID
95817
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Institutional, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
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
Batch or Lot Expiration Information
Lot# : 3115924, Exp. Date 06/2025
Affected Packages Involved in this Recall
51079-440-01Product
51079-440-20Product
51079-444-01Product
51079-444-20Product
51079-441-01Product
51079-441-20Product
51079-442-01Product
51079-442-20Product
51079-443-01Product
51079-443-20Product
51079-445-01Product
51079-445-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
