Levothyroxine Sodium Tablet
FDA Recall NDC 68180-968
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Levothyroxine Sodium (NDC 68180-968). A significant event, classified as Class II, was initiated on Dec 20, 2024 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2024 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Dec 20, 2024
Jan 08, 2025
480 1000-count bottles
Recall Profile & Regulatory Data
Event ID
95892
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
One US distributor in Ohio.
Termination Date
Feb 17, 2026
Product Description
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03
Batch or Lot Expiration Information
Lot# LA01276, Exp Date: 07/2026
Affected Packages Involved in this Recall
68180-965-03Product
68180-965-02Product
68180-965-09Product
68180-965-01Product
68180-966-03Product
68180-966-02Product
68180-966-09Product
68180-966-01Product
68180-967-03Product
68180-967-02Product
68180-967-09Product
68180-967-01Product
68180-968-09Product
68180-968-02Product
68180-968-01Product
68180-968-03Product
68180-969-01Product
68180-969-02Product
68180-969-03Product
68180-969-09Product
68180-970-01Product
68180-970-02Product
68180-970-03Product
68180-970-09Product
68180-971-01Product
68180-971-02Product
68180-971-03Product
68180-971-09Product
68180-972-01Product
68180-972-02Product
68180-972-03Product
68180-972-09Product
68180-973-01Product
68180-973-02Product
68180-973-03Product
68180-973-09Product
68180-974-01Product
68180-974-02Product
68180-974-03Product
68180-974-09Product
68180-975-03Product
68180-975-02Product
68180-975-01Product
68180-975-09Product
68180-976-01Product
68180-976-02Product
68180-976-03Product
68180-976-09Product
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.
