Levoxyl Tablets Recalled for Low Potency at Expiry
King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) when no hospitalizations or serious injuries are reported, as the risk is theoretical or temporary.
Plain-English summary
King Legacy, a wholly owned subsidiary of Pfizer, is recalling Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg. The recall involves 112,914 bottles of the prescription medication, which was 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.
Patients using Levoxyl should consult their healthcare provider for guidance on whether to continue using the medication or switch to an alternative. The specific lots affected include 64935, 65239, 65900, 66370, 66391, 64927, and 65240.
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
- 112,914
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 (12)
- Lot # a) 64935
- Exp. 5/13
- 65239
- Exp. 6/13
- 65900
- Exp. 8/13
- 66370
- Exp. 10/13
- and 66391
- Exp. 9/13
- b) 64927
- and 65240
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
- HighLevoxyl Levothyroxine Sodium Tablets Recalled for Low Potency
FDA (Drugs) · 2013-05-29
Same manufacturer · King Legacy, a wholly owned subsidiary of Pfizer
See all →- 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
- ModerateLevoxyl Levothyroxine Sodium Tablets Recalled for Low Potency
FDA (Drugs) · 2013-05-29
- ModerateKing Legacy Recalls Subpotent Levoxyl Levothyroxine Sodium Tablets
FDA (Drugs) · 2013-05-29
- ModerateLevoxyl tablets recalled for subpotent drug levels
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