Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LL...

FDA Drug Recall #D-0259-2026 - Class II, December 31, 2025

Recall Summary

Recall Number D-0259-2026
Classification Class II - Moderate risk
Date Initiated December 31, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alvogen, Inc
Location Morristown, NJ
Product Type Drugs

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.

Distribution Pattern

US Nationwide.

Lot / Code Information

Lot # MHA21825, Exp Date: December 31, 2027

Other Recalls from Alvogen, Inc

Recall # Classification Product Date
D-0245-2025 Class I Fentanyl Transdermal System CII, 25mcg/h, packa... Jan 31, 2025
D-0353-2023 Class II Levothyroxine Sodium Tablets, USP 112 mcg, 90 t... Feb 6, 2023
D-0649-2021 Class II Buprenorphine and Naloxone Sublingual Film 2mg/... Feb 26, 2021
D-1723-2019 Class II Macrobid Urinary Tract Anitbacterial, 100 mg, ... Jul 24, 2019
D-1722-2019 Class II Nitrofurantoin Monohydrate/Macrycrystals Capsul... Jul 24, 2019

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.