The Recall Desk
ModerateFDA (Drugs)·D-254-2013·Announced 2013-04-24

Pfizer Recalls Levoxyl Tablets Due to Strong Odor Contamination

Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after opening. Consumers should stop using the affected products.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a strong odor (chemical contamination) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pfizer Inc. is recalling Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, due to chemical contamination. The issue involves the emission of a strong odor after the package is opened. The recall affects 26,447 bottles of the 100-count and 1000-count packages distributed nationwide and in Puerto Rico.

The affected lots are 66619B (Exp. 11/13), 67010B (Exp. 01/14), 66733B (Exp. 11/13), and 67441B (Exp. 01/14). These products were manufactured and distributed by King Pharmaceuticals, Inc. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have these specific lots of Levoxyl should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall is limited to the specific lot numbers and expiration dates listed above.

The recalled product

Product
LEVOXYL (LEVOTHYROXINE SODIUM)
Brand
LEVOXYL
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
26,447

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 (6)

  • Lot # a) 66619B
  • Exp. 11/13
  • 67010B
  • Exp. 01/14
  • b) 66733B
  • 67441B

UPCs (11)

  • 0360793856018
  • 0360793850016
  • 0360793852010
  • 0360793851013
  • 0360793857015
  • 0360793853017
  • 0360793854014
  • 0360793858012
  • 0360793855011
  • 0360793859019
  • 0360793860015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Pfizer Inc. 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 11 products in this recall →

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