Levoxyl Levothyroxine Sodium Tablets Recalled for Low Potency
King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.
What this means for you
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 subpotent medication without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
King Legacy, a wholly owned subsidiary of Pfizer, is recalling Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg. The recall involves 195,201 bottles of the prescription medication, packaged in 100-count and 1,000-count bottles.
The products were recalled because they were below specification for potency at the expiry stability point. This means the medication may not contain the full amount of the active ingredient required to be effective.
The affected products were distributed nationwide and in Puerto Rico. Patients taking Levoxyl should contact their healthcare provider for guidance on alternative treatment options or replacement medication.
The recalled product
- Product
- LEVOXYL (LEVOTHYROXINE SODIUM)
- Brand
- LEVOXYL
- Manufacturer
- King Legacy, a wholly owned subsidiary of Pfizer
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 195,201
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 (20)
- Lot # a) 64341
- Exp 04/13
- 64928
- Exp. 5/13
- 65064
- 65233
- Exp. 7/13
- 66162
- Exp. 8/13
- 66365
- Exp. 10/13
- and 66677
- Exp. 11/13
- b) 64342
- Exp. 4/13
- 64929
- 65065
- 65234
- 65539
- 65901
UPCs (11)
- 0360793856018
- 0360793850016
- 0360793852010
- 0360793851013
- 0360793857015
- 0360793853017
- 0360793854014
- 0360793858012
- 0360793855011
- 0360793859019
- 0360793860015
Distribution
Part of a larger recall action
This product is one of 11 recalled by King Legacy, a wholly owned subsidiary of Pfizer 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
- ModerateKing Legacy Recalls Subpotent Levoxyl Levothyroxine Sodium Tablets
FDA (Drugs) · 2013-05-29
Same manufacturer · King Legacy, a wholly owned subsidiary of Pfizer
See all →- HighLevoxyl Levothyroxine Sodium Tablets Recalled for Low Potency
FDA (Drugs) · 2013-05-29
- ModerateLevoxyl Levothyroxine Sodium Tablets Recalled for Subpotency
FDA (Drugs) · 2013-05-29
- ModerateLevoxyl Tablets Recalled for Low Potency at Expiry
FDA (Drugs) · 2013-05-29
- HighLevoxyl Tablets Recalled for Low Potency at Expiry
FDA (Drugs) · 2013-05-29
- ModerateLevoxyl Levothyroxine Sodium Tablets Recalled for Low Potency
FDA (Drugs) · 2013-05-29
Same hazard · subpotent drug
See all →- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02