The Recall Desk
ModerateFDA (Drugs)·D-0405-2021·Announced 2021-06-02

Cardinal Health Recalls Synthroid Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 123 bottles of Synthroid (levothyroxine sodium) tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.

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 and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 123 bottles of Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles, and concentrations. The product is manufactured by Abbott Laboratories in North Chicago, IL, and is distributed in Florida, Georgia, and South Carolina. The recall is associated with code 1138959.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the medication.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.

The recalled product

Product
Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL
Affected units
123

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)

  • 1138959

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 →