The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-427-2013·Announced 2013-05-29

Levoxyl tablets recalled for subpotent levothyroxine sodium

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 is a reasonable probability of temporary or medically reversible adverse 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, 125 mcg. The affected products are packaged in 100-count bottles (NDC 60793-856-01) and 1000-count bottles (NDC 60793-856-10). The recall involves 103,796 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 active ingredient required to be effective.

Patients using Levoxyl should contact their healthcare provider for guidance on alternative treatment options. Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice to determine if they are affected.

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
103,796

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 (10)

  • Lot # a) 64333
  • Exp. 5/13
  • 64937
  • Exp. 6/13
  • 65629
  • Exp. 7/13
  • and 66296
  • Exp. 9/13
  • b) 64931
  • Exp. 5/13 and 65766

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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