Pfizer Recalls Levoxyl Tablets Due to Chemical Odor Contamination
Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong chemical 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 precautionary recall.
Plain-English summary
Pfizer Inc. is recalling 18,195 bottles of Levoxyl (levothyroxine sodium) tablets, USP 100 mcg. The affected products are packaged in 100-count bottles (NDC 60793-854-01) and 1,000-count bottles (NDC 60793-854-10). The recall covers Lot # 66897B (Expiration 12/13) and Lot # 67137B (Expiration 02/14).
The recall was initiated due to chemical contamination, specifically the emission of a strong odor after the package was opened. The products were distributed nationwide and in Puerto Rico.
Consumers who have these specific lots of Levoxyl should stop using them and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- LEVOXYL (LEVOTHYROXINE SODIUM)
- Brand
- LEVOXYL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 18,195
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) 66897B
- Exp. 12/13
- b) 67137B
- 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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