Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd ...

FDA Drug Recall #D-0353-2023 — Class II — February 6, 2023

Recall Summary

Recall Number D-0353-2023
Classification Class II — Moderate risk
Date Initiated February 6, 2023
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alvogen, Inc
Location Morristown, NJ
Product Type Drugs
Quantity 21,276 bottles

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.

Reason for Recall

Sub-Potent Drug: Out of specification for assay at the 24 month interval.

Distribution Pattern

Nationwide and Puerto Rico.

Lot / Code Information

Lot # HE02221, Exp. 05/2023

Other Recalls from Alvogen, Inc

Recall # Classification Product Date
D-0259-2026 Class II Levothyroxine Sodium Tablets, USP, Thyro-Tabs, ... Dec 31, 2025
D-0245-2025 Class I Fentanyl Transdermal System CII, 25mcg/h, packa... Jan 31, 2025
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 taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects 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.