Pfizer Recalls Levoxyl Tablets Due to Chemical Odor
Pfizer is recalling Levoxyl (levothyroxine sodium) 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 recall is classified as FDA Class II, and the hazard involves a chemical odor without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Pfizer Inc. is recalling Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, due to a chemical contamination issue. The affected product is packaged in 100-count and 1000-count bottles and is distributed nationwide and in Puerto Rico.
The recall was initiated because the tablets emit a strong odor after the package is opened. The specific lots involved are 66675B, 66852B, and 67138B, all with expiration dates in October 2013 or February 2014.
Consumers who have these specific bottles of Levoxyl should stop using the medication and contact their healthcare provider or pharmacist for guidance. The recall covers 23,210 bottles of the affected product.
The recalled product
- Product
- LEVOXYL (LEVOTHYROXINE SODIUM)
- Brand
- LEVOXYL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Thyroid Hormone
- Affected units
- 23,210
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 (5)
- Lot # a) 66675B
- Exp. 10/13
- b) 66852B Exp. 10/13
- 67138B
- Exp. 02/14
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 →Related recalls
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