The Recall Desk
ModerateFDA (Drugs)·D-421-2013·Announced 2013-05-29

King Legacy Recalls Subpotent Levoxyl Levothyroxine Sodium Tablets

King Legacy is recalling Levoxyl (levothyroxine sodium) 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 typically indicates a situation where use of the product might cause temporary or medically reversible health consequences. The hazard is subpotency (reduced effectiveness) rather than a direct toxic injury, fitting the Moderate category for low-risk contamination or labeling/potency issues without reported severe harm.

Plain-English summary

King Legacy, a wholly owned subsidiary of Pfizer, is recalling Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg. The affected products are packaged in 100-count bottles (NDC 60793-850-01) and 1,000-count bottles (NDC 60793-850-10). The recall involves 51,591 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 the active ingredient required to be effective.

Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the medication matches the recalled lots, patients should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

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
51,591

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 (8)

  • Lot # a) 65228
  • Exp. 06/13
  • 65636
  • Exp. 08/13
  • b) 65180
  • Exp. 05/13
  • 65769
  • Exp. 07/13

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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