The Recall Desk
ModerateFDA (Drugs)·D-257-2013·Announced 2013-04-24

Pfizer Recalls Levoxyl Tablets Due to Strong Odor Contamination

Pfizer is recalling Levoxyl (levothyroxine sodium) tablets because they emit a strong odor after the package is opened.

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, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or severe injuries are reported, fitting the criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

Pfizer Inc. is recalling Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, due to chemical contamination. The specific issue identified is the emission of a strong odor after the package is opened.

The recall affects 37,891 bottles of the medication, which are distributed nationwide and in Puerto Rico. The affected lots include 66373B, 66851B, 66792B, and 67349B, with expiration dates ranging from October 2013 to March 2014. The product is available in 100-count and 1000-count bottles.

Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LEVOXYL (LEVOTHYROXINE SODIUM)
Brand
LEVOXYL
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
37,891

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 (7)

  • Lot # a) 66373B
  • Exp. 10/13
  • 66851B
  • Exp. 12/13
  • b)66792B
  • 67349B
  • Exp. 03/14

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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