The Recall Desk
ModerateFDA (Drugs)·D-1694-2012·Announced 2012-10-03

Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms

Abbott Laboratories is recalling 53,448 bottles of Synthroid (levothyroxine sodium) 50 mcg tablets nationwide due to a defect in the bottle bottom that may affect tablet stability.

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 the hazard involves a potential impact on tablet stability due to a container defect, which fits the criteria for moderate severity without reported injuries.

Plain-English summary

Abbott Laboratories is recalling 53,448 bottles of Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, 90-Count. The recall affects bottles with the code 18265A8 and an expiration date of 09/20/2013. The product was distributed nationwide.

The recall was initiated because a number of the bottles have a localized thin wall defect on the bottom. This defect may potentially impact the stability of the tablets contained within the bottles.

Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II.

The recalled product

Product
SYNTHROID (LEVOTHYROXINE SODIUM)
Brand
SYNTHROID
Affected units
53,448

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 (2)

  • 18265A8
  • Exp 09/20/2013

UPCs (10)

  • 0300747149902
  • 0300747068197
  • 0300744341194
  • 0300745182192
  • 0300747070190
  • 0300747069903
  • 0300749296192
  • 0300743727906
  • 0300747148905
  • 0300746624905

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Abbott Laboratories 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 3 products in this recall →