The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-424-2013·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.

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 3/5 (High).

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

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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