The Recall Desk
HighFDA (Drugs)·D-431-2013·Announced 2013-05-29

Levoxyl Levothyroxine Sodium Tablets Recalled for Low Potency

King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

What this means for you

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, and the hazard involves a subpotent drug where the active ingredient is below specification, posing a risk of ineffective treatment for a chronic condition.

Plain-English summary

King Legacy, a wholly owned subsidiary of Pfizer, is recalling Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg. The recall involves 33,227 bottles, including 100-count and 1000-count packages, 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 contain the full amount of the active ingredient required to treat hypothyroidism effectively.

Patients using Levoxyl should contact their healthcare provider for guidance on alternative treatment options. The recall is limited to specific lot numbers and expiration dates: Lot # 64301 (Exp. 4/13), 65628 (Exp. 7/13), 64300 (Exp. 4/13), and 65765 (Exp. 7/13).

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
33,227

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 (5)

  • Lot # a) 64301
  • Exp. 4/13 and 65628
  • Exp. 7/13
  • b) 64300
  • Exp. 4/13 and 65765

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

See all →

Same hazard · subpotent drug

See all →