Levothyroxine Sodium Tablet
FDA Recall NDC 47781-643

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 2 recorded enforcement report(s) associated with Levothyroxine Sodium (NDC 47781-643). A significant event, classified as Class II, was initiated on Dec 31, 2025 by Alvogen, Inc.. The reported reason for this action was: "Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets."

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

D-0259-2026ONGOINGD-0353-2023TERMINATED

December 2025 Class II Recall: Product Mix-Up

Recall Number
D-0259-2026
Class II Ongoing
Reason for Recall
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Initiated
Dec 31, 2025
Reported
Jan 21, 2026
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
98225
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Alvogen, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.
Batch or Lot Expiration Information
Lot# MHA21825, Exp Date: December 31, 2027
Affected Packages Involved in this Recall
47781-640-90Product
47781-640-10Product
47781-643-90Product
47781-643-10Product
47781-646-90Product
47781-646-10Product
47781-649-90Product
47781-649-10Product
47781-651-90Product
47781-651-10Product
47781-654-90Product
47781-654-10Product
47781-657-90Product
47781-657-10Product
47781-659-90Product
47781-659-10Product
47781-662-90Product
47781-662-10Product
47781-665-90Product
47781-665-10Product
47781-668-90Product
47781-668-10Product
47781-671-90Product
47781-671-10Product

February 2023 Class II Recall: Sub-Potent Drug

Recall Number
D-0353-2023
Class II Terminated
Reason for Recall
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Initiated
Feb 06, 2023
Reported
Mar 08, 2023
Quantity
21,276 bottles

Recall Profile & Regulatory Data

Event ID
91654
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Alvogen, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Mar 18, 2024
Product Description
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
Batch or Lot Expiration Information
Lot# HE02221, Exp. 05/2023
Affected Packages Involved in this Recall
47781-640-90Product
47781-640-10Product
47781-643-90Product
47781-643-10Product
47781-646-90Product
47781-646-10Product
47781-649-90Product
47781-649-10Product
47781-651-90Product
47781-651-10Product
47781-654-90Product
47781-654-10Product
47781-657-90Product
47781-657-10Product
47781-659-90Product
47781-659-10Product
47781-662-90Product
47781-662-10Product
47781-665-90Product
47781-665-10Product
47781-668-90Product
47781-668-10Product
47781-671-90Product
47781-671-10Product

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.