The Recall Desk
ModerateFDA (Drugs)·D-426-2013·Announced 2013-05-29

Levoxyl Levothyroxine Sodium Tablets Recalled for Subpotency

King Legacy is recalling Levoxyl 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 typically associated with a temporary or medically reversible adverse health consequence. The hazard is subpotency, which is a quality issue rather than a contamination or acute injury risk, fitting the Moderate severity criteria for low-risk quality deviations without reported injuries.

Plain-English summary

King Legacy, a wholly owned subsidiary of Pfizer, is recalling Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg. The affected products are packaged in 100-count bottles (NDC 60793-855-01) and 1000-count bottles (NDC 60793-855-10). The recall involves 107,236 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 by the time the expiration date is reached.

Patients using Levoxyl should consult their healthcare provider for guidance on alternative treatment options. The specific lot numbers and expiration dates affected are: Lot # 64936 (Exp. 5/13), 65634 (Exp. 7/13), 66295 (Exp. 9/13), 66669 (Exp. 11/13) for 100-count bottles, and Lot # 65063 (Exp. 5/13), 65767 (Exp. 7/13) for 1000-count bottles.

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
107,236

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) 64936
  • Exp. 5/13
  • 65634
  • Exp. 7/13
  • 66295
  • Exp. 9/13
  • 66669
  • Exp. 11/13
  • b) 65063
  • Exp. 5/13 and 65767

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 · subpotency

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