The Recall Desk
ModerateFDA (Drugs)·D-260-2013·Announced 2013-04-24

Pfizer Recalls Levoxyl Tablets Due to Chemical Odor Contamination

Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after opening. The recall covers 10,121 bottles distributed nationwide and in Puerto Rico.

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 of 2, especially given the hazard is a strong odor without reported injuries or illnesses.

Plain-English summary

Pfizer Inc. is recalling 10,121 bottles of Levoxyl (levothyroxine sodium) tablets, USP 175 mcg. The affected products are packaged in 100-count and 1,000-count bottles and were distributed nationwide and in Puerto Rico. The specific lots involved are 67507B and 67508B, both with an expiration date of 02/14.

The recall was initiated due to chemical contamination, specifically the emission of a strong odor after the package was opened. This issue affects the identified prescription-only medication manufactured and distributed by King Pharmaceuticals, Inc.

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 classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
LEVOXYL (LEVOTHYROXINE SODIUM)
Brand
LEVOXYL
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
10,121

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 (3)

  • Lot # a) 67507B
  • Exp. 02/14
  • b) 67508B

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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