Medications & Supplements/Prescription Drugs

Pfizer Inc.: Levoxyl (Levothyroxine Sodium) Recalled for Being Superpotent

Agency Publication Date: December 18, 2018

Summary

Pfizer Inc. is recalling 1,996 bottles of Levoxyl (levothyroxine sodium) 112 mcg tablets because the medication was found to be superpotent, meaning the tablets contain more of the active ingredient than they should. This voluntary recall affects 100-count bottles of the prescription thyroid medication distributed nationwide. Consumers who have this medication should not use it as it may provide an incorrect dosage of the hormone levothyroxine.

Risk

Taking a superpotent dose of levothyroxine can lead to symptoms of hyperthyroidism, such as rapid or irregular heartbeat, tremors, anxiety, and weight loss. For patients with underlying heart conditions, this could increase the risk of serious cardiac events.

What You Should Do

Check your medication bottle for the brand name Levoxyl (levothyroxine sodium tablets, USP) 112 mcg in a 100-count size.
Verify the bottle information against the affected Lot #: 18A18 with an Expiration Date of 01/2020.
Confirm the National Drug Code (NDC) on the label is 60793-855-01.
Contact your healthcare provider or pharmacist immediately for guidance if you are currently taking medication from the affected lot.
Return any unused tablets from the recalled lot to your pharmacy for a refund and to obtain a safe replacement supply.
Contact Pfizer Inc. at 1-800-438-1985 for further instructions or to report any adverse effects related to this product.
For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Levoxyl (levothyroxine sodium tablets, USP) 112 mcg (100-count bottle)

Model:

NDC 60793-855-01

Recall #: D-0339-2019

Lot Numbers:

18A18 (Exp. 01/2020)

Date Ranges: Exp. 01/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81731

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 1996 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

Check your medication bottle for the brand name Levoxyl (levothyroxine sodium tablets, USP) 112 mcg in a 100-count size.

Verify the bottle information against the affected Lot #: 18A18 with an Expiration Date of 01/2020.

Confirm the National Drug Code (NDC) on the label is 60793-855-01.

Contact your healthcare provider or pharmacist immediately for guidance if you are currently taking medication from the affected lot.

Return any unused tablets from the recalled lot to your pharmacy for a refund and to obtain a safe replacement supply.

Contact Pfizer Inc. at 1-800-438-1985 for further instructions or to report any adverse effects related to this product.

For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.