Recall Enforment Report D-0259-2026

Recall Details

Drug Recall Enforcement Report Class II voluntary initiated by Alvogen, Inc, originally initiated on 12-31-2025 for the product 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. The product was recalled due to product mix-up: a single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 98225 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0259-2026 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern US Nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
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. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 01-21-2026
Recall Initiation Date 12-31-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Alvogen, Inc
Code Info Lot # MHA21825, Exp Date: December 31, 2027 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 47781-640-90; 47781-640-10; 47781-643-90; 47781-643-10; 47781-646-90; 47781-646-10; 47781-649-90; 47781-649-10; 47781-651-90; 47781-651-10; 47781-654-90; 47781-654-10; 47781-657-90; 47781-657-10; 47781-659-90; 47781-659-10; 47781-662-90; 47781-662-10; 47781-665-90; 47781-665-10; 47781-668-90; 47781-668-10; 47781-671-90; 47781-671-10
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
47781-640Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-643Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-646Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-649Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-651Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-654Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-657Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-659Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-662Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-665Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-668Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug
47781-671Levothyroxine Sodium Levothyroxine SodiumTabletOralAlvogen, Inc.Human Prescription Drug