Medications & Supplements/Prescription Drugs

Westminster Pharmaceuticals LLC: Levothyroxine and Liothyronine Tablets Recalled for Incorrect Dosage Strength

Agency Publication Date: August 23, 2018

Summary

Westminster Pharmaceuticals, LLC has recalled various strengths of Levothyroxine and Liothyronine (Thyroid Tablets, USP) sold in 100-count bottles. These prescription thyroid medications were manufactured using an adulterated active ingredient and lacked proper quality controls, causing some tablets to have more or less medication than stated on the label. This recall affects several strengths ranging from 1/4 grain to 2 grains. Consumers should consult their healthcare provider or pharmacist immediately, as thyroid levels must be carefully managed.

Risk

The tablets may contain incorrect amounts of active medication due to poor manufacturing practices. Patients receiving too little thyroid hormone may experience symptoms of hypothyroidism like fatigue and weight gain, while too much hormone can cause hyperthyroidism, leading to heart palpitations, anxiety, or more serious cardiovascular issues.

What You Should Do

Identify your medication by checking the label for 'Levothyroxine and Liothyronine (Thyroid Tablets, USP)' in 100-count bottles manufactured for Westminster Pharmaceuticals, LLC.
Check your bottle for the following NDC numbers: 69367-156-04 (1 grain), 69367-157-04 (1 1/2 grain), 69367-155-04 (1/2 grain), 69367-159-04 (1/4 grain), or 69367-158-04 (2 grain).
Verify the Lot Number and Expiration Date on your bottle. Affected lots include 15617VP03, 15617VP01, 15617VP-02 (Exp 7/31/2019); 15617VP06, 15617VP05 (Exp 11/30/2019); 15617VP04, 15618004, 15618002 (Exp 12/31/2019); 15618009, 15618008 (Exp 2/29/2020); 15618011 (Exp 3/31/2020) for 1 grain tablets; 15717VP-01, 15717VP-02, 15717VP-03 (Exp 7/31/2019); 15717002 (Exp 12/31/2019); 15718004 (Exp 3/31/2020) for 1 1/2 grain tablets; 15517VP01, 15517VP02, 15517VP03 (Exp 8/31/2019); 15518001 (Exp 12/31/2019); 15518002 (Exp 3/31/2020) for 1/2 grain tablets; 15917VP03, 15917VP02, 15917VP01 (Exp 10/31/2019); 15918004, 15918003, 15918002, 15918001 (Exp 12/31/2019); 15918VP03, 15918VP02, 15918VP01, 15918005 (Exp 2/29/2020); 15918007, 15918006 (Exp 3/31/2020) for 1/4 grain tablets; and 15817VP-01, 15817VP-02, 15817VP-03 (Exp 9/30/2019); 15818001 (Exp 3/31/2020) for 2 grain tablets.
Contact your healthcare provider or pharmacist immediately to discuss a replacement prescription. Do not stop taking your medication without a doctor's advice, as sudden discontinuation of thyroid hormone can be harmful.
Return any unused product to your pharmacy for a refund and contact Westminster Pharmaceuticals LLC at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.
For further questions or to report a side effect, call the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Contact healthcare provider and return product to pharmacy.

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

Affected Products

Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottle

Model:

NDC 69367-156-04

Recall #: D-1178-2018

Lot Numbers:

15617VP03 (Exp 7/31/2019)

15617VP01 (Exp 7/31/2019)

15617VP-02 (Exp 7/31/2019)

15617VP06 (Exp 11/30/2019)

15617VP05 (Exp 11/30/2019)

15617VP04 (Exp 12/31/2019)

15618004 (Exp 12/31/2019)

15618002 (Exp 12/31/2019)

15618009 (Exp 2/29/2020)

15618008 (Exp 2/29/2020)

15618011 (Exp 3/31/2020)

Date Ranges: Exp 7/31/2019 - 3/31/2020

Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 1/2 grain (90 mg), 100-count bottle

Model:

NDC 69367-157-04

Recall #: D-1179-2018

Lot Numbers:

15717VP-01 (Exp 7/31/2019)

15717VP-02 (Exp 7/31/2019)

15717VP-03 (Exp 7/31/2019)

15717002 (Exp 12/31/2019)

15718004 (Exp 3/31/2020)

Date Ranges: Exp 7/31/2019 - 3/31/2020

Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottle

Model:

NDC 69367-155-04

Recall #: D-1180-2018

Lot Numbers:

15517VP01 (Exp 8/31/2019)

15517VP02 (Exp 8/31/2019)

15517VP03 (Exp 8/31/2019)

15518001 (Exp 12/31/2019)

15518002 (Exp 3/31/2020)

Date Ranges: Exp 8/31/2019 - 3/31/2020

Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottle

Model:

NDC 69367-159-04

Recall #: D-1181-2018

Lot Numbers:

15917VP03 (Exp 10/31/2019)

15917VP02 (Exp 10/31/2019)

15917VP01 (Exp 10/31/2019)

15918004 (Exp 12/31/2019)

15918003 (Exp 12/31/2019)

15918002 (Exp 12/31/2019)

15918001 (Exp 12/31/2019)

15918VP03 (Exp 2/29/2020)

15918VP02 (Exp 2/29/2020)

15918VP01 (Exp 2/29/2020)

15918005 (Exp 2/29/2020)

15918007 (Exp 3/31/2020)

15918006 (Exp 3/31/2020)

Date Ranges: Exp 10/31/2019 - 3/31/2020

Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottle

Model:

NDC 69367-158-04

Recall #: D-1182-2018

Lot Numbers:

15817VP-01 (Exp 9/30/2019)

15817VP-02 (Exp 9/30/2019)

15817VP-03 (Exp 9/30/2019)

15818001 (Exp 3/31/2020)

Date Ranges: Exp 9/30/2019 - 3/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80719

Status: Resolved

Manufacturer: Westminster Pharmaceuticals LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 5 products (Unknown; Unknown; Unknown; Unknown; Unknown)

Distributed To: Nationwide

Agency Last Updated: September 7, 2018

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

Risk

What You Should Do

Identify your medication by checking the label for 'Levothyroxine and Liothyronine (Thyroid Tablets, USP)' in 100-count bottles manufactured for Westminster Pharmaceuticals, LLC.

Check your bottle for the following NDC numbers: 69367-156-04 (1 grain), 69367-157-04 (1 1/2 grain), 69367-155-04 (1/2 grain), 69367-159-04 (1/4 grain), or 69367-158-04 (2 grain).

Verify the Lot Number and Expiration Date on your bottle. Affected lots include 15617VP03, 15617VP01, 15617VP-02 (Exp 7/31/2019); 15617VP06, 15617VP05 (Exp 11/30/2019); 15617VP04, 15618004, 15618002 (Exp 12/31/2019); 15618009, 15618008 (Exp 2/29/2020); 15618011 (Exp 3/31/2020) for 1 grain tablets; 15717VP-01, 15717VP-02, 15717VP-03 (Exp 7/31/2019); 15717002 (Exp 12/31/2019); 15718004 (Exp 3/31/2020) for 1 1/2 grain tablets; 15517VP01, 15517VP02, 15517VP03 (Exp 8/31/2019); 15518001 (Exp 12/31/2019); 15518002 (Exp 3/31/2020) for 1/2 grain tablets; 15917VP03, 15917VP02, 15917VP01 (Exp 10/31/2019); 15918004, 15918003, 15918002, 15918001 (Exp 12/31/2019); 15918VP03, 15918VP02, 15918VP01, 15918005 (Exp 2/29/2020); 15918007, 15918006 (Exp 3/31/2020) for 1/4 grain tablets; and 15817VP-01, 15817VP-02, 15817VP-03 (Exp 9/30/2019); 15818001 (Exp 3/31/2020) for 2 grain tablets.

Contact your healthcare provider or pharmacist immediately to discuss a replacement prescription. Do not stop taking your medication without a doctor's advice, as sudden discontinuation of thyroid hormone can be harmful.

Return any unused product to your pharmacy for a refund and contact Westminster Pharmaceuticals LLC at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.

For further questions or to report a side effect, call the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottle

Model:

NDC 69367-156-04

Recall #: D-1178-2018

Lot Numbers:

15617VP03 (Exp 7/31/2019)

15617VP01 (Exp 7/31/2019)

15617VP-02 (Exp 7/31/2019)

15617VP06 (Exp 11/30/2019)

15617VP05 (Exp 11/30/2019)

15617VP04 (Exp 12/31/2019)

15618004 (Exp 12/31/2019)

15618002 (Exp 12/31/2019)

15618009 (Exp 2/29/2020)

15618008 (Exp 2/29/2020)

15618011 (Exp 3/31/2020)

Date Ranges: Exp 7/31/2019 - 3/31/2020

Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 1/2 grain (90 mg), 100-count bottle

Model:

NDC 69367-157-04

Recall #: D-1179-2018

Lot Numbers:

15717VP-01 (Exp 7/31/2019)

15717VP-02 (Exp 7/31/2019)

15717VP-03 (Exp 7/31/2019)

15717002 (Exp 12/31/2019)

15718004 (Exp 3/31/2020)

Date Ranges: Exp 7/31/2019 - 3/31/2020

Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottle

Model:

NDC 69367-155-04

Recall #: D-1180-2018

Lot Numbers:

15517VP01 (Exp 8/31/2019)

15517VP02 (Exp 8/31/2019)

15517VP03 (Exp 8/31/2019)

15518001 (Exp 12/31/2019)

15518002 (Exp 3/31/2020)

Date Ranges: Exp 8/31/2019 - 3/31/2020

Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottle

Model:

NDC 69367-159-04

Recall #: D-1181-2018

Lot Numbers:

15917VP03 (Exp 10/31/2019)

15917VP02 (Exp 10/31/2019)

15917VP01 (Exp 10/31/2019)

15918004 (Exp 12/31/2019)

15918003 (Exp 12/31/2019)

15918002 (Exp 12/31/2019)

15918001 (Exp 12/31/2019)

15918VP03 (Exp 2/29/2020)

15918VP02 (Exp 2/29/2020)

15918VP01 (Exp 2/29/2020)

15918005 (Exp 2/29/2020)

15918007 (Exp 3/31/2020)

15918006 (Exp 3/31/2020)

Date Ranges: Exp 10/31/2019 - 3/31/2020

Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottle

Model:

NDC 69367-158-04

Recall #: D-1182-2018

Lot Numbers:

15817VP-01 (Exp 9/30/2019)

15817VP-02 (Exp 9/30/2019)

15817VP-03 (Exp 9/30/2019)

15818001 (Exp 3/31/2020)

Date Ranges: Exp 9/30/2019 - 3/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80719

Status: Resolved

Manufacturer: Westminster Pharmaceuticals LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 5 products (Unknown; Unknown; Unknown; Unknown; Unknown)

Distributed To: Nationwide

Agency Last Updated: September 7, 2018