Pfizer Recalls Levoxyl Tablets Due to Strong Odor Contamination
Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after opening. Consumers should stop using the affected products.
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 specific hazard is a strong odor (chemical contamination) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pfizer Inc. is recalling Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, due to chemical contamination. The issue involves the emission of a strong odor after the package is opened. The recall affects 26,447 bottles of the 100-count and 1000-count packages distributed nationwide and in Puerto Rico.
The affected lots are 66619B (Exp. 11/13), 67010B (Exp. 01/14), 66733B (Exp. 11/13), and 67441B (Exp. 01/14). These products were manufactured and distributed by King Pharmaceuticals, Inc. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
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 limited to the specific lot numbers and expiration dates listed above.
The recalled product
- Product
- LEVOXYL (LEVOTHYROXINE SODIUM)
- Brand
- LEVOXYL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 26,447
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 (6)
- Lot # a) 66619B
- Exp. 11/13
- 67010B
- Exp. 01/14
- b) 66733B
- 67441B
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
Same brand · LEVOXYL
- HighLevoxyl 50 microgram levothyroxine tablets recalled as a subpotent drug
FDA (Drugs) · 2025-08-20
- ModerateCardinal Health Recalls LEVOXYL Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- SeverePfizer Recalls Levoxyl Levothyroxine Sodium Tablets Due to Superpotency
FDA (Drugs) · 2018-12-26
- SeverePfizer Recalls LEVOXYL Levothyroxine Sodium Tablets Due to Superpotency
FDA (Drugs) · 2016-11-30
- ModerateLevoxyl tablets recalled for subpotent levothyroxine sodium
FDA (Drugs) · 2013-05-29
Same manufacturer · Pfizer Inc.
See all →- HighSodium bicarbonate injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighEpinephrine injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighBicillin L-A 2.4 million unit vials recalled after particulates found
FDA (Drugs) · 2025-08-06
- HighBicillin L-A penicillin vials recalled after particulates found during visual inspection
FDA (Drugs) · 2025-08-06
- ModerateDobutamine Injection Recall Due to Discoloration and Cracked Vials
FDA (Drugs) · 2025-07-02
Same hazard · chemical contamination
See all →- ModerateAvid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls Craniotomy Packs Due to Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls Plastic Trays Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
Similar recalls
- SeverePfizer Recalls Levoxyl Levothyroxine Sodium Tablets Due to Superpotency
FDA (Drugs) · 2018-12-26
- HighLevoxyl 50 microgram levothyroxine tablets recalled as a subpotent drug
FDA (Drugs) · 2025-08-20
- HighLevoxyl Levothyroxine Sodium Tablets Recalled for Low Potency
FDA (Drugs) · 2013-05-29
- HighLevoxyl Tablets Recalled for Low Potency at Expiry
FDA (Drugs) · 2013-05-29
- ModerateLevoxyl tablets recalled for subpotent levothyroxine sodium
FDA (Drugs) · 2013-05-29
- ModerateLevoxyl Recall: Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2013-05-29