The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-425-2013·Announced 2013-05-29

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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

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 →

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