The Recall Desk
ModerateFDA (Drugs)·D-0557-2021·Announced 2021-06-02

Cardinal Health Recalls LEVOXYL Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 13 bottles of LEVOXYL tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

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, but the hazard is a storage deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 13 bottles of LEVOXYL (levothyroxine sodium) tablets, 150mcg, 100-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product is identified by lot code 20D27 and NDC 60793-858-01. The product was distributed in Florida, Georgia, and South Carolina. LEVOXYL is a prescription medication manufactured in Austria and distributed by Pfizer Inc.

Consumers with this product should contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LEVOXYL (LEVOTHYROXINE SODIUM)
Brand
LEVOXYL
Affected units
13

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 (1)

  • 20D27

UPCs (11)

  • 0360793856018
  • 0360793850016
  • 0360793852010
  • 0360793851013
  • 0360793857015
  • 0360793853017
  • 0360793854014
  • 0360793858012
  • 0360793855011
  • 0360793859019
  • 0360793860015

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. 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 198 products in this recall →