Thyroid Tablet Recall Issued Over Banned Ingredients in Levothyroxine and Liothyronine

Westminster Pharmaceuticals, LLC has issued a recall for certain thyroid medications, after it was discovered that they were improperly manufactured and may contain banned ingredients that pose a health risk for patients. 

The FDA announced a Levothyroxine and Liothyronine thyroid tablet recall on August 9, warning that multiple lots could be contaminated  due to problems during the manufacturing and distribution processes. To date, no injuries or illnesses have been reported in relation to the recall.

According to the recall notice, the thyroid medications contain active ingredients that were flagged in 2017, during an FDA inspection that found deficiencies with Current Good Manufacturing Practices (cGMP). The notice indicated the substandard manufacturing processes could present a risk of injury or illnesses to patients receiving the medication.

The recalled thyroid tablets include Levothyroxine and Liothyronine 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg doses, which are designed for oral use as a replacement or supplemental therapy in patients with hypothyroidism, a condition in which the thyroid gland doesn’t produce enough thyroid hormone.

Since the prescriptions are used for the treatment of serious medical conditions, the FDA is warning that patients should not stop taking the medications until they have consulted with their healthcare provider and have been prescribed an appropriate alternative.

The thyroid tablets were manufactured by Westminster Pharmaceuticals, LLC of Tampa, Florida and were sold in 100-count bottles. The medications were distributed throughout the United States to Westminster direct accounts. For a full list of the recalled thyroid medications, please visit the FDA recall notice.

Westminster Pharmaceuticals has begun notifying its direct accounts by email and phone to immediately discontinue distributing the products, and to follow instructions on the mailed Recall Notice Letter and Recall Response Form to return any remaining inventory to the manufacturer.

Customers with additional questions or concerns may contact Westminster Regulatory Affairs department at 888-354-9939 or email them at recalls@wprx.com. Patients and medical professionals are encouraged to report adverse health consequences to the FDA’s MedWatch Adverse Event Reporting program either online or by fax.