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.
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, 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
- 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 →Related recalls
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Similar recalls
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