Levoxyl tablets recalled for subpotent drug levels
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, which typically indicates a situation where use of the product might cause temporary or medically reversible health consequences. The hazard is subpotency (lack of efficacy) rather than toxicity or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
King Legacy, a wholly owned subsidiary of Pfizer, is recalling Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg. The recall involves 194,142 bottles of the prescription medication, which were distributed nationwide and in Puerto Rico.
The FDA classified this as a Class II recall because the products were below specification for potency at the expiry stability point. This means the medication may not have been effective at the end of its labeled shelf life.
Consumers with these products should contact their healthcare provider for guidance. The specific lot numbers and expiration dates affected are listed in the official recall notice.
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
- 194,142
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 (18)
- Lot # a) 64197
- Exp. 4/13
- 64339
- 65061
- Exp. 5/13
- 65236
- Exp. 6/13
- 65917
- Exp. 8/13
- 66122
- and 66427
- Exp. 9/13
- b) 64340
- 64933
- 65062
- 65237
- 65238
- and 66121
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
- ModerateLevoxyl Tablets Recalled for Low Potency at Expiry
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 →- ModerateAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02