Levothyroxine Sodium Tablet
FDA Recall NDC 42292-040
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Levothyroxine Sodium (NDC 42292-040). A significant event, classified as Class II, was initiated on Nov 19, 2024 by Mylan Institutional Inc.. The reported reason for this action was: "Subpotent and Superpotent Drug"
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
Subpotent and Superpotent Drug
Nov 19, 2024
Dec 18, 2024
205 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, 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: 42292-040-20
Batch or Lot Expiration Information
Lot# : 3115869, Exp. Date 03/2025
Affected Packages Involved in this Recall
42292-038-01Product
42292-038-20Product
42292-039-01Product
42292-039-20Product
42292-041-01Product
42292-041-20Product
42292-040-01Product
42292-040-20Product
Class II Ongoing
Subpotent and Superpotent Drug
Nov 19, 2024
Dec 18, 2024
988 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, 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: 42292-039-20
Batch or Lot Expiration Information
Lot# : 3115707, Exp. Date 02/2025
Affected Packages Involved in this Recall
42292-038-01Product
42292-038-20Product
42292-039-01Product
42292-039-20Product
42292-041-01Product
42292-041-20Product
42292-040-01Product
42292-040-20Product
Class II Ongoing
Subpotent and Superpotent Drug
Nov 19, 2024
Dec 18, 2024
1,133 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, 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: 42292-041-20
Batch or Lot Expiration Information
Lot# : 3115448, Exp. Date 12/31/2024;3115732, Exp. Date 3/31/2025; 3116024, Exp. Date 9/30/2025
Affected Packages Involved in this Recall
42292-038-01Product
42292-038-20Product
42292-039-01Product
42292-039-20Product
42292-041-01Product
42292-041-20Product
42292-040-01Product
42292-040-20Product
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.
