The Recall Desk
CriticalFDA (Drugs)·D-1178-2018·Announced 2018-08-29

FDA Recalls Levothyroxine and Liothyronine Thyroid Tablets Due to Content Uniformity Failures

Westminster Pharmaceuticals is recalling specific lots of Levothyroxine and Liothyronine tablets because they failed content uniformity specifications due to an adulterated ingredient.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

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 grain (60 mg), 100-count bottles. The product is manufactured for Westminster Pharmaceuticals, LLC, and is available by prescription only. The recall covers specific lot numbers with expiration dates ranging from July 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 products were distributed nationwide in the USA and Puerto Rico. Patients and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund.

The recalled product

Product
Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.
Manufacturer
Westminster Pharmaceuticals LLC
Category
Drug — Thyroid Medication
Hazard

Is your product affected?

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

Lot numbers (16)

  • Lot #: 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.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Westminster Pharmaceuticals LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Westminster Pharmaceuticals LLC

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Same hazard · content uniformity

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