Medications & Supplements/Prescription Drugs

Alvogen Levothyroxine Sodium Tablets Recalled for Sub-Potency

Agency Publication Date: February 24, 2023

Summary

Alvogen, Inc. has recalled 21,276 bottles of Levothyroxine Sodium Tablets, USP (112 mcg), a medication used to treat thyroid conditions. Testing at the 24-month mark revealed the tablets were sub-potent, meaning they contained less of the active ingredient than specified. No injuries or medical incidents have been reported in connection with this issue. This recall affects 90-count bottles distributed to pharmacies nationwide.

Risk

Sub-potent medication may not provide the full dose of thyroid hormone required by the patient, potentially leading to symptoms of an underactive thyroid (hypothyroidism). These symptoms can include fatigue, weight gain, and cold intolerance.

What You Should Do

This recall involves 90-count bottles of Levothyroxine Sodium Tablets, USP 112 mcg, which were distributed nationwide by Alvogen Inc.
To identify if your medication is affected, look for NDC 47781-654-90, lot number HE02221, and an expiration date of 05/2023 on the prescription bottle label.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Alvogen, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Levothyroxine Sodium Tablets, USP (112 mcg)

Variants: 112 mcg, 90 tablets per bottle

Lot Numbers:

HE02221 (Exp. 05/2023)

NDC:

47781-654-90

Manufactured by Lloyd Inc., Shenandoah, IA; Distributed by Alvogen Inc, Pine Brook, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91654

Status: Resolved

Manufacturer: Alvogen, Inc

Sold By: pharmacies

Manufactured In: United States

Units Affected: 21,276 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves 90-count bottles of Levothyroxine Sodium Tablets, USP 112 mcg, which were distributed nationwide by Alvogen Inc.

To identify if your medication is affected, look for NDC 47781-654-90, lot number HE02221, and an expiration date of 05/2023 on the prescription bottle label.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Alvogen, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.