FDA Recalls Levothyroxine and Liothyronine Tablets Due to Content Uniformity Failures

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottles. The product is manufactured for Westminster Pharmaceuticals, LLC, and is available by prescription only. The recall covers specific lots with expiration dates ranging from August 31, 2019, to March 31, 2020.

The recall was initiated because the product was manufactured using an adulterated active pharmaceutical ingredient. Additionally, a lack of process controls and good manufacturing practices resulted in the finished product failing content uniformity specifications. This failure means the tablets may contain a strength that is more or less than what is labeled on the bottle.

The affected product was distributed nationwide in the United States and Puerto Rico. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatment options. Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice.

The recalled product

Product

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-155-04.

Manufacturer

Westminster Pharmaceuticals LLC

Category

Drug — Prescription Medication

Hazard

• adulterated-ingredient
• content-uniformity-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls