The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-256-2013·Announced 2013-04-24

Pfizer Recalls Levoxyl Tablets Due to Strong Odor Emission

Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after the package is opened.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 FDA classified this as a Class II recall. The hazard involves a strong odor indicating chemical contamination, which is a quality defect but does not meet the criteria for severe injury or death.

Plain-English summary

Pfizer Inc. is recalling 9,213 bottles of Levoxyl (levothyroxine sodium) tablets, USP 112 mcg. The affected products are packaged in 100-count bottles (NDC 60793-855-01) and 1,000-count bottles (NDC 60793-855-10). The recall covers Lot # 67343B (Exp. 01/14) and Lot # 66902B (Exp. 12/13). These prescription-only medications were distributed nationwide and in Puerto Rico.

The recall was initiated due to chemical contamination, specifically the emission of a strong odor after the package was opened. The FDA has classified this as a Class II recall.

Consumers who have these specific lots of Levoxyl should stop using the product and contact their healthcare provider or pharmacist for guidance. The product was manufactured and distributed by King Pharmaceuticals, Inc., Bristol, TN.

The recalled product

Product
LEVOXYL (LEVOTHYROXINE SODIUM)
Brand
LEVOXYL
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
9,213

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 (4)

  • Lot # a) 67343B
  • Exp. 01/14
  • b) 66902B
  • Exp. 12/13

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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