The Recall Desk
ModerateFDA (Drugs)·D-422-2013·Announced 2013-05-29

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

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 subpotency (low potency) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

King Legacy, a wholly owned subsidiary of Pfizer, is recalling Levoxyl (levothyroxine sodium) tablets. The affected products are 50 mcg tablets packaged in 100-count and 1000-count bottles. The recall involves 195,699 bottles distributed nationwide and in Puerto Rico.

The recall was initiated because the products were below specification for potency at the expiry stability point. This means the medication may not contain the full intended amount of the active ingredient when it reaches its expiration date.

Consumers with these specific lot numbers should contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment. The affected lots include 64934, 65059, 65179, 65630, 65916, 66367, 66718, 64338, 64932, 65060, 65235, 65853, and 65962.

The recalled product

Product
LEVOXYL (LEVOTHYROXINE SODIUM)
Brand
LEVOXYL
Manufacturer
King Legacy, a wholly owned subsidiary of Pfizer
Category
Drug — Thyroid Hormone
Hazard
Affected units
195,699

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) 64934
  • Exp. 4/13
  • 65059
  • Exp. 5/13
  • 65179
  • 65630
  • Exp. 7/13
  • 65916
  • Exp. 8/13
  • 66367
  • Exp. 10/13
  • and 66718
  • Exp. 11/13
  • b) 64338
  • 64932
  • 65060
  • 65235
  • Exp. 6/13
  • 65853
  • and 65962

UPCs (11)

  • 0360793856018
  • 0360793850016
  • 0360793852010
  • 0360793851013
  • 0360793857015
  • 0360793853017
  • 0360793854014
  • 0360793858012
  • 0360793855011
  • 0360793859019
  • 0360793860015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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

Same manufacturer · King Legacy, a wholly owned subsidiary of Pfizer

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Same hazard · subpotency

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