The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-423-2013·Announced 2013-05-29

Levoxyl tablets recalled for subpotent drug levels

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, which typically indicates a situation where use of the product might cause temporary or medically reversible health consequences. The hazard is subpotency (lack of efficacy) rather than toxicity or contamination, and no injuries or illnesses are reported in the source text.

Plain-English summary

King Legacy, a wholly owned subsidiary of Pfizer, is recalling Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg. The recall involves 194,142 bottles of the prescription medication, which were 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.

Consumers with these products should contact their healthcare provider for guidance. The specific lot numbers and expiration dates affected are listed in the official recall notice.

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
194,142

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 (18)

  • Lot # a) 64197
  • Exp. 4/13
  • 64339
  • 65061
  • Exp. 5/13
  • 65236
  • Exp. 6/13
  • 65917
  • Exp. 8/13
  • 66122
  • and 66427
  • Exp. 9/13
  • b) 64340
  • 64933
  • 65062
  • 65237
  • 65238
  • and 66121

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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