The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1695-2012·Announced 2012-10-03

Abbott Recalls Synthroid Tablets Due to Container Wall Defect

Abbott Laboratories is recalling 42,596 bottles of Synthroid (levothyroxine sodium) 75 mcg tablets due to a localized thin wall defect on the bottle bottom that may impact tablet stability.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 potential stability issue due to a container defect, which aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls without reported injuries.

Plain-English summary

Abbott Laboratories is voluntarily recalling 42,596 bottles of Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, 90-Count. The recall is limited to Lot 18353A8 with an expiration date of 08/31/2013. 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 lot of Synthroid should stop using the product and contact their healthcare provider or pharmacist for guidance. The FDA classifies this recall as Class II, indicating that 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
Manufacturer
Abbott Laboratories
Category
Drug — Prescription Medication
Hazard
Affected units
42,596

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: 18353A8
  • Exp 08/31/2013

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 →

Related recalls

Same brand · SYNTHROID

Same manufacturer · Abbott Laboratories

See all →

Same hazard · container defect

See all →

Similar recalls