The Recall Desk
ModerateFDA (Drugs)·D-1696-2012·Announced 2012-10-03

Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms

Abbott Laboratories is recalling 40,464 bottles of Synthroid (levothyroxine sodium) 112 mcg tablets nationwide. The recall addresses a localized thin wall defect on the bottom of some bottles that may impact 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, but the source text describes a container defect that 'may potentially impact' stability without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving potential but unreported harm or precautionary measures.

Plain-English summary

Abbott Laboratories is voluntarily recalling 40,464 bottles of Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, 90-Count. The affected product is identified by Lot 18355A8 and has an expiration date of 09/26/13. The recall is being conducted 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 lot of Synthroid should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
SYNTHROID (LEVOTHYROXINE SODIUM)
Brand
SYNTHROID
Affected units
40,464

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)

  • Lot: 18355A8
  • Exp. 09/26/13

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 →