Pfizer Recalls Levoxyl Tablets Due to Strong Odor Contamination
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 recall is classified as FDA Class II, but the hazard is a strong odor (chemical contamination) with no reported illnesses or injuries, fitting the 'low-risk contamination' or 'voluntary precautionary' criteria for a Moderate score.
Plain-English summary
Pfizer Inc. is recalling 14,464 bottles of Levoxyl (levothyroxine sodium) tablets, USP 200 mcg. The affected products are packaged in 100-count and 1,000-count bottles and were distributed nationwide and in Puerto Rico. The recall involves specific lot numbers with expiration dates of 11/13 and 02/14.
The recall was initiated due to chemical contamination, specifically the emission of a strong odor after the package was opened. No illnesses or injuries have been reported in connection with this issue.
Consumers who have these specific bottles should stop using the product and contact their healthcare provider or pharmacist for guidance. The product is prescription-only, so patients should consult their prescriber before discontinuing or switching medications.
The recalled product
- Product
- LEVOXYL (LEVOTHYROXINE SODIUM)
- Brand
- LEVOXYL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 14,464
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) 66671B
- Exp. 11/13
- 67512B
- Exp. 02/14 b) 66739B Exp. 11/13
- 67513B 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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