Pfizer Recalls Levoxyl Tablets Due to Chemical Odor Contamination
Pfizer is recalling specific lots of Levoxyl (levothyroxine sodium) 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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a chemical odor, which is a quality defect rather than a direct toxicological threat, fitting the Moderate category for low-risk contamination or labeling/quality errors.
Plain-English summary
Pfizer Inc. is recalling 36,045 bottles of Levoxyl (levothyroxine sodium) tablets, USP 150 mcg. The affected products are packaged in 100-count and 1,000-count bottles and were distributed nationwide and in Puerto Rico. The recall is due to chemical contamination, specifically the emission of a strong odor after the package was opened.
The affected lots are 66375B (expiration 10/13), 66719B (expiration 01/14), and 66904B (expiration 01/14). The product is a prescription-only medication manufactured and distributed by King Pharmaceuticals, Inc. in Bristol, TN.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using the affected medication.
The recalled product
- Product
- LEVOXYL (LEVOTHYROXINE SODIUM)
- Brand
- LEVOXYL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 36,045
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) 66375B
- Exp. 10/13
- 66719B
- Exp. 01/14
- b) 66904B
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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