The Recall Desk
ModerateFDA (Drugs)·D-430-2013·Announced 2013-05-29

Levoxyl Levothyroxine Sodium Tablets Recalled for Low Potency

King Legacy is recalling Levoxyl (levothyroxine sodium) 175 mcg 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 is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a potency issue (subpotent drug) without reported injuries or deaths, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

King Legacy, a wholly owned subsidiary of Pfizer, is recalling Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg. The affected products are packaged in 100-count bottles (NDC 60793-859-01) and 1000-count bottles (NDC 60793-859-10). The recall involves 51,438 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 amount of the active ingredient required by the standard.

Patients using Levoxyl should contact their healthcare provider for guidance on alternative treatment options. The specific lots affected include 64329, 65229, and 65913 for 100-count bottles, and 64330, 65230, and 65915 for 1000-count bottles, with expiration dates ranging from May 2013 to September 2013.

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
51,438

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 (9)

  • Lot # a) 64329
  • Exp. 5/13
  • 65229
  • Exp. 6/13
  • and 65913
  • Exp. 9/13
  • b) 64330
  • 65230
  • and 65915

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 · subpotent drug

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