Medications & Supplements/Prescription Drugs

Synthroid (levothyroxine sodium) Recalled for Incorrect Barcode Labeling

Agency Publication Date: November 5, 2023

Summary

AbbVie Inc. is recalling 864 cartons of Synthroid (levothyroxine sodium) Tablets, USP 125mcg (0.125mg), because some unit dose blisters contain a barcode error. Approximately one out of every 40 unit dose blisters contains an incorrect barcode that causes the 125mcg dose to be scanned as a 200mcg dose. This recall affects 100-count bottles from lot 1187435 with an expiration date of February 2024.

Risk

The incorrect barcode could lead to medication errors if a healthcare provider or pharmacist relies on a scan to verify the dosage, potentially resulting in a patient receiving a higher dose of thyroid medication than prescribed.

What You Should Do

This recall affects Synthroid (levothyroxine sodium) Tablets, USP 125mcg (0.125mg), sold in 100-count bottles under NDC 0074-7068-11 and lot number 1187435 with an expiration date of 02/2024.
Check the medication bottle or outer packaging for NDC 0074-7068-11 and lot number 1187435 to determine if your prescription is part of this recall.
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 AbbVie Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Synthroid (levothyroxine sodium) Tablets, USP (100-count bottle)

Variants: 125mcg (0.125mg), 100-count bottle

Lot Numbers:

1187435 (Exp 02/2024)

NDC:

0074-7068-11

One (1) of every forty (40) unit dose blister contains an incorrect barcode identifying the 125mcg dose as a 200mcg dose.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93202

Status: Active

Manufacturer: AbbVie Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 864 cartons

Distributed To: Nationwide

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 affects Synthroid (levothyroxine sodium) Tablets, USP 125mcg (0.125mg), sold in 100-count bottles under NDC 0074-7068-11 and lot number 1187435 with an expiration date of 02/2024.

Check the medication bottle or outer packaging for NDC 0074-7068-11 and lot number 1187435 to determine if your prescription is part of this recall.

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 AbbVie Inc. for further instructions.

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