Pfizer Recalls Levoxyl Tablets Due to Chemical Odor Contamination
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 moderate severity.
Plain-English summary
Pfizer Inc. is recalling Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, due to chemical contamination. The specific issue identified is the emission of a strong odor after the package is opened.
The recall affects 29,613 bottles of the medication, which are distributed nationwide and in Puerto Rico. The affected products are packaged in 100-count and 1,000-count bottles. Specific lot numbers and expiration dates are listed in the official recall documentation.
Consumers who have purchased Levoxyl tablets should check their bottles against the recall details provided by the FDA. If the product matches the recalled lots, patients should stop using the medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- LEVOXYL (LEVOTHYROXINE SODIUM)
- Brand
- LEVOXYL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 29,613
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 (11)
- Lot # a) 66730B
- 66853B
- Exp. 01/14
- b) 66731B
- 67116B
- Exp. 11/13
- 66856B
- Exp. 12/13
- 67341B
- 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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Similar recalls
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